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We are currently conducting a search on behalf of our client for an Associate Director, Brand Marketing. This is a direct hire position with the client organization and will be based in Berkeley Heights, NJ. The Associate Director, Brand Marketing, will support the development and commercialization of key brand initiatives across multiple therapeutic areas. This highly visible role will lead the execution of aligned marketing tactics across Healthcare Professional (HCP) and Consumer/Patient audiences, spanning personal promotion, non-personal promotion, digital media, communications, public relations, and additional strategic channels. This individual will work both independently and cross-functionally with internal stakeholders including field sales, medical affairs, commercial strategy and operations, market access, and promotional review. The ideal candidate thrives in a fast-paced, dynamic environment and brings strong communication, organization, and collaboration skills. This is an exciting opportunity to join a growing biotechnology organization and play a key role in driving successful brand growth and commercialization. What’s in it for you? • Comprehensive Medical, Dental & Vision Insurance, • Basic and Voluntary Life and AD&D Insurance, • Short- and Long-Term Disability Insurance, • Flexible Spending Accounts (FSA) and Health Savings Account (HSA), • Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401(k) with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, and Paid Holidays, • Career Development and Training What will you be doing? • Maintain a detailed understanding of disease states and competitive marketplace dynamics to inform brand strategy, • Lead the development and execution of marketing tactics aligned to overall brand strategy across HCP and Consumer/Patient audiences, • Manage agency partners to ensure deliverables are on-strategy, on-time, and within budget, • Collaborate with cross-functional teams to support commercialization initiatives and optimize launch and lifecycle efforts, • Partner closely with field sales and market access teams to ensure alignment and effective pull-through of marketing initiatives, • Ensure all promotional materials comply with regulatory and promotional review requirements, • Contribute innovative thinking to brand initiatives and identify opportunities to elevate execution and impact, • Support business performance tracking and adjust tactics as needed to achieve brand objectives What do you need for this position? • Bachelor’s Degree (BA/BS) in Business, Marketing, or related discipline required, • MBA preferred, • 7+ years of pharmaceutical or biotechnology marketing experience, • Experience supporting product or indication launches, • Strong understanding of pharmaceutical marketing processes and regulatory requirements, • Experience managing agency partners, • Experience collaborating with field-based sales teams and understanding market access considerations, • Demonstrated ability to successfully achieve business objectives, • Excellent interpersonal, oral, and written communication skills, • Strong project management skills with the ability to manage multiple priorities, • Experience working with Key Opinion Leaders preferred, • Experience in pharmaceutical sales preferred, • Therapeutic experience in CNS, primary care, rheumatology, pain, or related specialties preferred About Inizio Engage Inizio Engage is a strategic, commercial, and creative engagement partner that specializes in healthcare. Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people and providers to improve treatment outcomes. Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need. We believe in our values: We empower everyone/We rise to the challenge/We work as one/We ask what if/We do the right thing, and we will ask you how your personal values align to them. To learn more about Inizio Engage, visit us at: ___ Inizio Engage is proud to be an equal opportunity employer. Individuals seeking employment at Inizio are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Inizio will consider for employment qualified applicants with arrest and conviction records. Inizio Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however, only qualified candidates will be considered.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Associate Director, Health Authorities will aid the advance of global clinical regulatory compliance for investigational and marketed products and manage the preparation, review, and finalization of submission packages and responses to Health Authorities. This position will contribute to the preparation of INDs, CTAs, BLAs, MAAs, and any other application for health authorities in line with local requirements. Essential Functions • Lead Health Authorities direct reports by delegating projects, establishing and meeting timelines, and ensuring high quality work products, • Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance., • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, data management plan, and any other clinical trial associated document, • Provide input to the design and reporting of clinical studies sponsored by IBRX, • Manage the preparation of the relevant clinical sections of written summaries for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and any other applications., • Create and maintain project plans for health authorities operations, • Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies, • Lead external stakeholder engagement throughout the submission lifecycle, coordinating with CROs, external regulatory consultants, and subject matter experts / key opinion leaders to gather data, craft highquality RFI responses, and foster constructive agency relationships, • Prepare and assign responses to Health Authority comments and questions pertaining to clinical issues. Maintain timelines on responses and assemble the final, completed submission package., • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Ensure continuous monitoring of, and incorporation of, the most recent regional and local healthauthority guidances; interpret amendments and apply updated requirements to all regulatory dossiers to mitigate agency queries and preserve submission integrity, • Oversee versioncontrol governance by supervising a centralized document repository, defining namingconvention standards, authorizing changetracking procedures, and approving final module versions prior to electronic upload to ensure auditready documentation, • Develop and maintain productdevelopment road maps based on projected approval dates, • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required., • Experience managing staff required, • Experience in the management and preparation of the submission of clinical modules in eCTD format required., • Experience in medical writing, • Experience with organizing responses to Health Authority information requests required., • Experience with regulatory submissions outside of the US preferred Knowledge, Skills, & Abilities • Expert knowledge of Health Authority guidance documents and requirements, • Strong leadership skills with the ability to direct and develop professional staff, • Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • Expert knowledge of clinical documentation, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail, • Ability to successfully manage multiple changing deadlines and operate in ambiguity Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval, • This position may need to sit for long periods of time and use various computer programs, • This desk-based role involves the close study of scientific and regulatory documents, • This position will work closely with scientific colleagues throughout the day, often on a project-team basis This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $185,000 (entry-level qualifications) to $203,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

About Pharming PharmingHealthcare Inc.is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, witha significant proportionof its employees based in the U.S. Our Vision Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets,leveragingproven and efficient clinical development, supply chain, and commercial infrastructure. #Life at Pharming Today, more than ever, we're positioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyone's commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, #Life at Pharming, which is dynamic, experimental, and shaped by what we learn together. We are looking for people who are excited about our vision and living our values: • We put Patients at the heart, • We act with urgency, • We make it simple, • We get it done Summary The Senior Clinical Data Manager (Sr. CDM) serves as the primary inhouse data management expert within a near-to-fully outsourced clinical execution model. This role provides strategic oversight and handson leadership of all data management activities across the development programs in the Pharming portfolio. This includes building fit for purpose data capture systems, database cleaning, and coordination of third-party data transfers to facilitate trial reporting. The Sr. CDM will work closely with our CROs and vendors who prosecute these activities and with the internal/external biostatistics team and importantly will be an integral part of our matrixed clinical development teams. The goal of this role will be to ensure timely, accurate, and compliant data delivery across the Pharming portfolio. The Sr. CDM ensures endtoend data quality, SDTM/ADaM traceability, and the accuracy of all statistical outputs, including tables, listings, and figures (TLFs), that support interim analyses, topline readouts, and regulatory filings. Responsibilities General Clinical Data Management and Data Related Vendor Oversight: • Provide expert guidance on data implications for protocol design, endpoints, and operational feasibility., • Act as the primary liaison between Pharming and vendor data management and biostatistics teams., • Review and approve CRO plans, including Data Management Plans, CRF completion guidelines, edit check specifications, and data review plans., • Oversee CRO and vendor performance, ensuring adherence to timelines, data quality standards, and contractual deliverables., • Partner closely with Clinical team members, Safety and Regulatory to ensure crossfunctional alignment on data strategy. Other Responsibilites: • Support the development of study-specific database builds using study protocol and configuration specifications, including performance of the User Acceptance Testing (UAT)., • Review SAPs and TLF mock shells for feasibility, completeness, and alignment with collected data, and ensure complete endtoend traceability: CRF SDTM ADaM TLF outputs., • Periodically conduct targeted QC of key listings (e.g., AEs, SAEs, ConMeds, labs, vitals, exposure, efficacy assessments) to identify outliers, missing data, unexpected patterns, and data inconsistencies; drive their resolution with CROs., • Manage clinical data cleaning and delivery activities, including (soft)database lock, for interim analyses, DMC/DSMB reviews, and final CSR., • Ensure all data cut and database lock criteria are met and documented., • Ensure alignment between data management findings and statistical programming outputs., • Ensure AE/SAE data quality, including reconciliation with safety narratives and coding consistency (e.g., MedDRA)., • Validate treatmentemergent flags, exposure metrics, and safety population definitions produced by CRO partners., • Lead TFL review workshops and data review meetings with Medical, Safety, and Clinical Ops., • Manage adhoc biostatistics and data requests from Health Authorities (e.g., FDA, EMA) during NDA/BLA review and coordinate rapidturnaround analyses and data outputs with CRO Biostats/Programming., • Support data output and review for medical and scientific presentations/publications., • Collaborate with Regulatory Affairs to track requests, ensure timely responses, and document resolutions., • Drive both strategy and delivery of all data management related items., • Other duties as assigned. Qualifications • At least 6 years of clinical data management experience in the pharmaceutical/biotech industry, preferably in a small biotech., • Bachelor's or Master's degree in a scientific or technical discipline., • Expertise with EDC systems (e.g., Rave, Veeva, Inform) and vendor data pipelines., • Solid understanding of SAS outputs, derivations, and dataset structures (SAS programming experience a plus but not required)., • Proficiency with CDISC standards, Pinnacle 21, and submission metadata tools., • Experience using AI tools to enhance work product and increase efficiency., • Proven experience overseeing outsourced DM/Biostats activities., • Experience supporting regulatory submissions (NDA/BLA) preferred., • Commitment and alignment to Pharming's mission, core values and behaviors. Salary Range The base salary range for this job is from $130,000 to $170,000 per year.Pharming takes into consideration a combination of candidate's work experience, training, and education, as well as the scope of the role, complexity, and external market and internal value when determining a salary level. Compensation & Benefits • A fully remote work schedule, • Competitive compensation package including annual target bonus, • Long-term incentive program, • 401(k) plan with company match, • Paid Time Off (PTO), • 13 Company Holidays per year Other Benefits • Excellent benefit plans including medical, dental, and vision, • Flexible spending accounts, • Company-provided life insurance, short-term disability, and long-term disability plans, • Optional accident, hospital indemnity, critical illness, and pet insurance plans, • Tuition reimbursement program, • Health and wellness program, • Choice of company provided mobile phone or cell phone stipend Additional Information Pharming Healthcare, Inc. is a merit-based equal opportunity employer. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected classes. An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to ___. Unsolicited resumes from agencies should not be forwarded to Pharming. Pharming will not be responsible for any fees arising from the use of resumes through this source. Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established. The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Veeva RIM Specialist will provide expertise and guidance in the management and publishing of regulatory documents ensuring their conformance with Health Authority requirements. This role is hands on and execution focused, working closely with all of regulatory affairs to support all US and ex-US regulatory activities and maintain inspection-ready system. This position will assist staff in submission and document management activities using Veeva RIM software. Essential Functions • Create and maintain electronic project folders for projects., • Execute the upload, tracking, life cycle maintenance of regulatory submissions, including INDs, BLAs, CTAs, for US and ex-US regions within Veeva RIM., • Maintain Veeva RIM by uploading all submissions, Health Authority correspondence, etc., • Track all regulatory meetings, questions, information requests, and responses ensuring proper linking within Veeva RIM. Upload and manage Word and source documents in Veeva Vault to support collaboration, version control, and document updates., • Ensure regulatory documents received via email, secure links, or external portals in addition to gateway submissions are captured and filed appropriately., • Assist in responding to internal audits, health authority inspections, and regulatory inquiries related to RIM documentation., • Ensure that all working files, forms, sign-out sheets, and archives are organized and maintained in accordance with SOPs and Health Authority requirements., • Configure Vault objects, lifecycles, workflows, document types, and metadata to support business processes., • Provide technical and functional support for users including, but not limited to, access to Veeva RIM, • Assist in system validation, upgrades, and testing, ensuring compliance with GxP and regulatory standards., • Partner with regulatory affairs, IT, and clinical teams to translate business requirements into technical solutions., • Assist in training Regulatory Documentation Specialists, ensuring that all SOPs are followed, and all questions are answered; Continue to provide support and assist in questions after the training is completed., • Act as a key operational contact for Regulatory Affairs regarding Veeva RIM., • Provide day-to-day support to system users., • Collaborate with other Regulatory Documentation Specialists regarding upgrades to existing software programs, new software programs, or removing software programs that are no longer needed., • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 5+ years of regulatory operations experience in the biotechnology or pharmaceutical industry required; or, • High School diploma with 9+ years' experience required., • Hands on experience with Veeva RIM and Veeva Vault required., • Familiarity with global regulatory submissions and health authority correspondence strongly preferred. Knowledge, Skills, & Abilities • Expert knowledge of Health Authority procedures and guidance regarding document management and electronic submission., • Expert knowledge of Electronic Document Management Systems., • Strong knowledge in Veeva Vault especially Veeva RIM., • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities., • Strong organizational skills, written and oral communication skills, and attention to detail. Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves close study of scientific and regulatory documents., • This position will work closely with colleagues throughout the day, often on a project-team basis. This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $50.48 (entry-level qualifications) to $55.53 (highly experienced) per hour The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Principal Scientist, Regulatory CMC will report to the Director, Regulatory CMC and be responsible for participating in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format. The Principal Scientist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs). Key responsibilities will include contributing to the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions • Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards, • Contribute to the development of global CMC regulatory strategies, • Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation, • Provide expert opinion on CMC topics planned or performed, • Contribute to the design of CMC protocols, • Interact with other groups when needed to address CMC related matters, • Assist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues, • Train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate, • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years relevant progressive experience required, • Experience in the preparation of the submission of CMC modules in eCTD format required, • Familiarity with organizing responses to Health Authority requests required, • Familiarity with regulatory submissions outside of the US desired Knowledge, Skills, & Abilities • Knowledge of Health Authority procedures and guidance regarding document management and electronic submission, • Knowledge of Health Authority CMC guidance documents and requirements, • Proficient in Electronic Document Management Systems, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail, • Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred Working Environment / Physical Environment • This position works on-site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents. $170,000 (entry-level qualifications) to $187,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Manager, Veeva RIM will provide strategic and strategic leadership and oversight for Veeva RIM. The manager will manage the day-to-day management and operations of Veeva RIM, ensuring accurate, timely, and compliant uploads and maintenance of regulatory submissions and related documentation across US and ex-US regions. This role parents closely with Clinical, Nonclinical, and CMC regulatory teams to support all regulatory activities. This position will assist and direct staff in the use of Veeva RIM software to ensure that all regulatory content, submissions, and processes are managed efficiently, accurately, and in full compliance with global regulations. Essential Functions • Lead the Regulatory Affairs Veeva RIM Team by delegating projects, establishing and meeting timelines, and ensuring high quality work products., • Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees, and monitoring performance., • Manage dossier archiving and ensure regulatory data integrity, version control, and audit readiness., • Use Veeva RIM to upload and manage all regulatory submissions (e.g., BLA, IND, CTA), registrations, and archival of documents for both US and ex-US., • Upload, track, and maintain all correspondence with health authorities as well as ethic committees., • Partner with IT, Quality, and clinical on system support activities as needed., • Partner with IT, Quality, and clinical on system validation, upgrades, and testing, ensuring compliance with GxP and regulatory standards., • Ensure all regulatory questions, requests, and responses are accurately uploaded and linked properly in Veeva RIM., • Upload and maintain all Word and source documents in the Veeva Vault to enable version control, collaboration, and document updates., • Manage documents received but not limited to via regulatory gateways, emails, secure links., • Establish and maintain RIM-related SOPs, work instructions, and best practices., • Lead or support migration of regulatory and submission documents from legacy systems to Veeva., • Maintain full lifecycle document management: authoring, reviewing, approval, version control, metadata, retention., • Track regulatory submission, • Ensure all regulatory questions, requests, and responses are accurately uploaded and linked properly in Veeva RIM., • Upload and maintain all Word and source documents in the Veeva Vault to enable version control, collaboration, and document updates., • Manage documents received but not limited to via regulatory gateways, emails, secure links., • Establish and maintain RIM-related SOPs, work instructions, and best practices., • Lead or support migration of regulatory and submission documents from legacy systems to Veeva., • Maintain full lifecycle document management: authoring, reviewing, approval, version control, metadata, retention., • Track regulatory submission renewals, post-approval changes, and ensure timelines are met., • Monitor regulatory guidance and changes, perform impact assessment; communicate changes to cross-functional teams., • Ensure compliance with relevant regulatory requirements (FDA, EMA, ICH, local authorities), • Ensure that all working files and archives are organized and maintained in accordance with SOPs and Health Authority requirements, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications., • Provide user support/training for Veeva workflows; act as tool superuser., • Train and support cross-functional uses on Veeva RIM processes and document standards., • Prepare for internal/external audits, inspections, and data integrity assessments, address findings promptly., • Act as a point of contact for troubleshooting Veeva RIM issues and coordinating with system administrators., • Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 7+ years of regulatory operation experience in the biotech or pharmaceutical industry required; or, • High School diploma with 11+ years of regulatory operation experience in the biotech or pharmaceutical industry required., • Familiarity with global regulatory submissions (US and ex-US)., • 2 years of experience managing regulatory documentation using Veeva RIM required., • 2+ years of experience managing staff in support of Regulatory Affairs operations is preferred. Knowledge, Skills, & Abilities • Leadership skills with the ability to direct and develop professional staff, • Strong knowledge of Health Authority guidance documents and requirements., • Strong knowledge of Health Authority procedures and guidance regarding document management and electronic submission., • Strong knowledge of the use of Veeva RIM in document management., • Strong attention to detail and document management skills., • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities., • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $165,000 (entry-level qualifications) to $181,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Manager, Lifecycle Maintenance will advance the maintenance global clinical regulatory compliance for investigational and marketed products and manage the maintenance of study files in eCTD format. This position will contribute to the organization in the design and conduct of clinical trials in conformance with Health Authority requirements and the management of clinical trial documentation to support clinical submissions. Essential Functions • Lead Lifecycle Maintenance staff by delegating projects, establishing and meeting timelines, and ensuring high quality work products, • Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance., • Provide input to the design and reporting of clinical studies performed by IBRX or by CROs, • Manage the review, cataloguing, and submission of documents including investigator brochures, protocols, informed consent forms, clinical study reports, annual reports, DSURs, PSURs, PAERs, and clinicaltrials.gov entries in the US and abroad, • Manage all protocol supportive documentation including the cataloguing and submission of essential investigator qualification documents, • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan, • Create and maintain project plans for regulatory lifecycle maintenance operations, • Monitor FDA and other healthauthority guidance, prepare supplemental dossiers, and manage the lifecycle documentation for postapproval changes., • Lead datadriven strategic initiatives to maintain comprehensive regulatory documentation, ensuring compliance and supporting organizational objectives., • Oversee configuration, maintenance, and user support for internal platforms used for file storage., • Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Manage the internal review of the relevant clinical sections of written summaries for regulatory submissions including INDs, NDAs, and BLAs, • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 7+ years relevant progressive experience required; or, • Master's degree in life sciences or technical discipline with 5+ years relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 3+ years relevant progressive experience required, • Experience managing staff preferred, • Experience in the management and preparation of the submission of clinical modules in eCTD format required, • Experience with organizing responses to Health Authority information requests required, • Familiarity with global regulatory submissions (US and ex-US) strongly preferred Knowledge, Skills, & Abilities • Strong knowledge of Health Authority guidance documents and requirements, • Strong leadership skills with the ability to direct and develop professional staff, • Strong knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval, • This position may need to sit for long periods of time and use various computer programs, • This desk-based role involves the close study of scientific and regulatory documents, • This position will work closely with scientific colleagues throughout the day, often on a project-team basis This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $165,000 (entry-level qualifications) to $181,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Associate Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format. The Associate Director will have one or more direct reports, will work closely with cross-functional teams on CMC regulatory strategy and regional regulatory requirements, and will consult with CMC subject matter experts (SMEs). Key responsibilities will include the development of Health Authority submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions • Provide expert opinion on CMC topics planned or performed, • Manage the preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards, • Assist with the development of global CMC regulatory strategies, • Prepare or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation, • Provide expert opinion on CMC topics planned or performed, • Assist with the design of CMC protocols, • Collaborate with other groups when needed to address CMC related matters, • Prepare responses to Health Authority comments and questions pertaining to CMC issues, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance, • Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required., • Experience in the management and preparation of the submission of CMC modules in eCTD format required, • Experience with organizing responses to Health Authority requests required, • Experience with regulatory submissions outside of the US preferred, • Experience managing staff preferred Knowledge, Skills, & Abilities • Strong knowledge of Health Authority CMC guidance documents and requirements, • Good leadership skills with the ability to direct and develop professional staff, • Expert knowledge of Chemistry, Manufacturing and Controls of a medical product and related regulatory requirements and guidelines, • Expert knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred, • Ability to manage work and staff with firm deadlines and adapt quickly to changing requirements and priorities, • Excellent organizational skills, written and oral communication skills, and attention to detail Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents., • This position will work closely with scientific colleagues throughout the day, often on a project team basis., • This position may also need to travel to meet with Regulatory Agencies, attend conferences, or visit manufacturing sites. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $200,000 (entry-level qualifications) to $220,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Regulatory Affairs Program Manager leads crossfunctional regulatory projects from strategy through execution, ensuring that all products meet global regulatory requirements and are launched on schedule. This role partners closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission timelines, and drive successful product approvals worldwide. Essential Functions • Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies., • Function as a Regulatory Affairs point of contact for internal teams, translating regulatory requirements into clear and actionable objectives., • Coordinate crossfunctional project teams, ensuring alignment with regulatory objectives and strategy. Track and report program status to senior leadership and external partners., • Conduct regulatory intelligence to anticipate changes in laws, guidance, and standards. Assess impact on products/processes and communicate findings., • Identify risks early, develop mitigation plans, and resolve issues that could impact timelines or approvals., • Foster a culture of continuous improvement and regulatory excellence., • Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates., • Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's degree in sciences, business, project management or a related field with 7+ years of relevant progressive experience is required., • 5+years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred., • 3+years managing complex, multiregional regulatory programs is preferred. Knowledge, Skills, & Abilities • Understanding and knowledge of FDA and other major healthauthority requirements, a plus., • Proven ability to work with crossfunctional teams, manage budgets, and deliver on schedule., • Excellent written and oral communication skills., • Strong analytical and problemsolving abilities., • Proficiency with MS Office suites and project management tools. Working Environment / Physical Environment • This position works on-site, • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer., • Lift and carry materials weighing up to 30 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $141,300 (entry-level qualifications) to $157,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: ___ Global Medical Affairs (GMA) at PTC is committed to helping health care providers make evidence-based decisions to optimize health outcomes in their patients with rare diseases. The Associate Vice President (AVP), GMA-Metabolism is responsible for defining the GMA vision, strategy and tactics to support PTC's metabolism business, currently focused on PKU. He/she will work directly with VP, GMA on various strategic initiatives and serve as deputy to the VP, GMA. He/she will partner with the Regional Medical Directors to identify and develop relationships with key opinion leaders (KOLs), identify treatment centers, ensure that the global medical affairs strategies and tactics for PKU are adopted and implemented at the local level and to ensure that the Global vision, strategy and tactics meet local needs. He/she collaborates with marketing colleagues, to ensure that the strategic PKU medical affairs plan is aligned with the brand strategy. He/she will partner with the GMA enabling functions (i.e. Publications, Medical Information, Medical Education, Medical Communications, etc.) to lead and execute the medical strategy for Sepiapterin, which includes: updating/executing established medical plan, maintaining the scientific communication platform (publications, congresses etc.), planning and executing scientific advisory boards, review and approval of all grants (including IIS requests) and creating and delivering educational presentations both internally and externally. This individual will represent GMA on existing program team for Sepiapterin, providing input into clinical development initiatives related to Sepiapterin and will also support all life-cycle management initiatives. This role is viewed as the medical affairs subject matter expert on PKU and is expected to play a key role in educating KOLs, physicians, and internal colleagues. This position ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Responsibilities: • Develops and leads strategic global medical affairs activities related to PKU to accelerate commercialization efforts in launched markets and support successful commercialization in other markets to launch., • Drives and supports communication and collaboration amongst regional and local Medical Affairs functions, GMA enabling functions and other teams in Commercial, Market Access, etc. to ensure well developed and executed PKU strategic plans; drives internal cross-functional partnerships for all PKU medical initiatives., • Serves as the PKU subject matter expert in Global Medical Affairs. Partners with medical and commercial training to educate internal and external colleagues on the scientific and clinical aspects of PKU., • Develops and finalizes global evidence generation plan in close collaboration with regional and country medical heads, GMA enabling functions and ensures alignment with other key internal stakeholders., • Plans and leads the Investigator Initiated Studies (IIS) strategy for PKU., • Effectively engages and builds relationships with PKU KOLs, internal and external stakeholders and healthcare professionals for the successful implementation of medical strategy for PKU; identifies and engages in scientific exchange with medical experts in the PKU therapeutic area., • Serves as the strategic partner with respect to PKU to Clinical Development, Commercial Development and Life-Cycle Management (LCM) teams., • Represents Global Medical Affairs at international and regional scientific congresses., • Collaborates closely with the Marketing function to provide medical input for commercial activities related to therapy., • Plans and leads the publication strategy for PKU., • Supervises medical information process and service from the PKU indication perspective in close collaboration with other functions in medical affairs; ensures Medical Services offerings are appropriately utilized for PKU. Qualifications: • Advanced Degree Required (PharmD, PhD or MD) with a minimum experience of 15 years progressively responsible experience in the pharmaceutical, biotechnology or related environment, preferably with a minimum of 10 years in medical affairs., • Prior experience as a Global or Regional Medical Lead (supporting the U.S.) within a rare disease; experience within metabolism and also leading various medical affairs functions, strongly preferred, • Special knowledge or skills needed and/or licenses or certificates required., • Experience supporting key markets (including US), • Proven track record of successful leadership and progression within a medical affairs department working from both a strategic and tactical standpoint., • Demonstrated ability to accurately and effectively evaluate medical/scientific literature and develop effective medical and communication strategies., • Ability to analyze data and synthesize a compelling scientific narrative tailored to relevant audiences., • Demonstrated track record of success supporting the commercialization of an orphan, rare disease and/or specialized drug(s)., • In-depth experience dealing with payer organizations., • Demonstrated ability to create and lead cross-functional teams., • Demonstrated ability to develop relationships with and influence KOLs, important customers, challenge common perceptions and implement medical affairs tools to improve patient care and outcomes., • Ability to influence without direct authority., • Proficiency with Microsoft Office., • Excellent verbal and written communication and skills., • Ability to take complex scientific information and communicate it clearly and effectively to diverse audiences in a clear and concise manner, • Ability to work effectively in a global, multicultural environment, • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members., • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines., • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects., • Fluent in English (verbal and written). *Special knowledge or skills and/or licenses or certificates preferred. • Expertise on PKU or related inborn errors of metabolism, • Experience in orphan/rare diseases, neurology and/or genetic disorders., • Knowledge of US Market (payors and KOL interactions), • Experience in leading medical affairs functions or team Travel requirements: 40% global travel Office-based or remote position with travel to PTC offices and off-site meetings as needed. Candidates must be based in the U.S. (East-coast). Expected Base Salary Range: $331,200 - $389,600. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: ___ The Senior Vice President, Clinical Development is responsible for providing strategic leadership for the clinical/medical aspects of all phases of drug development across all therapeutic areas, compounds and/or indications. The incumbent is accountable for ensuring that clinical trials and protocols are properly designed and executed in accordance with applicable Good Clinical Practice (GCP) regulations. He/she is also accountable for defining and leading the strategic design of programs/studies such that there is strategic alignment across the portfolio. The role provides oversight for the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical and regulatory objectives, and the documentation of study results. This includes, but may not be limited to, overseeing the activities of the Clinical organization. The incumbent is a key representative of PTC's clinical development organization in meetings with external stakeholders and audiences as needed; he/she may also author, or review for scientific/ medical purposes, clinical/medical-related materials intended for internal and/or external audiences. He/she manages direct and indirect reports. The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues. The Senior Vice President, Clinical Development is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. . ESSENTIAL FUNCTIONS Primary duties/responsibilities: * Provides strategic and technical guidance and leads the global clinical development strategy for all therapeutic areas, compounds, and/or indications from pre-IND registration through late stage clinical development (which may include post-registration required studies) ensures the design of Clinical Development Plans (CDPs) to enable PTC to: 1) demonstrate clinical/medical benefit(s) and 2) achieve compound and business objectives; provides clinical/medical input to non-clinical and commercial functions on matters related to these objectives. * Directs relationships with external partners (e.g. vendors, consultants, collaborators, etc.); monitors program/study budgets to ensure the timely and cost-effective implementation of CDP(s); reviews and approves contracts, work orders, and invoices within grant of authority; participates in the assessment of CROs, vendors, consultants or other partners as necessary. * In partnership with the Development Leadership Team, contributes to ensuring all Development functions are, and remain, strategically aligned to the company's goals and to Development's objectives. * Provides input into Clinical Development oversight through the Development Leadership Review meetings * Partners with other core functions (e.g. Clinical Operations, Regulatory Affairs, Pharmacovigilance and Biostatistics/Data Management, etc...) to ensure that clinical development activities are defined and executed in a manner that is compliant and achieves clinical and regulatory milestones. * Facilitates communication and collaboration with internal, cross-functional team members (e.g. research, manufacturing, drug supply, regulatory, quality, project management, marketing, domestic and international regulatory authorities, etc.) to support CDPs, regulatory submissions and corporate goals. * Ensures adherence to the highest scientific, ethical, and regulatory standards and ensures compliance with all applicable GCP regulatory requirements. * May represent PTC's Clinical development team in meetings with external collaborators regarding the status of partnered clinical development projects. * May support the assessment of in-licensing product candidates in area of expertise, as needed. * Interacts with Health Authorities including, but not limited to, Food and Drug Administration (FDA) and European Medicines Agency (EMA). * Manages, coaches and mentors direct and indirect reports. * Performs other tasks and assignments as needed and specified by management. KNOWLEDGE/SKILLS/ABILITIES REQUIRED • Minimum level of education and years of relevant work experience. MD degree and a minimum of 12 years progressively responsible and strategic experience in clinical drug development (minimum of 6 years in a clinical leadership role) in a pharmaceutical, biotechnical, CRO or related environment and/or a minimum of 12 years of related professional experience in these same environments. • Special knowledge or skills needed and/or licenses or certificates required. Strategic vision-setting abilities coupled with entrepreneurial, hands on approach. * Excellent, hands-on clinical trial design leadership and data interpretation experience. * Thorough working knowledge across a broad range of areas of drug development. * Hands-on New Drug Applications (NDAs)/Marketing Authorization Applications (MAA) submission experience. * Hands-on experience successfully developing, registering, and supporting compounds throughout their lifecycle. * Regulatory experience; significant interaction with health authorities within and outside of the U.S. (FDA, EMA, PMDA, etc.) * Hands-on experience managing multiple therapeutic areas and/or compounds. * Demonstrated leadership ability and experience managing, coaching and mentoring direct reports. * Ability to influence without direct authority. * Proficiency with Microsoft Office. * Excellent verbal and written communication and skills. Must have the ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena. * Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. * Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. * Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. *Special knowledge or skills and/or licenses or certificates preferred. * Global experience. * Experience working in rare/orphan disease research. • Travel requirements Up to 40% Expected Base Salary Range $425,000 - 485,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Job Title : Regulatory Affairs Associate Location : Clark, NJ 07066 Duration : 12 Months Shift Details : On-Site Job Description : • Review formulas for compliance with local regulations, in particular for US and Canada, • Reviewing artwork for US and Canada Compliance, • Notifying products in US and Canada as needed, • Canada Chemical regulatory oversight and review, • Preparing registration documents as needed Qualifications: • Bachelors level degree in Science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs., • Experience in drug or cosmetic industry

Job Description About the Role: The Elevator Inspector plays a critical role in ensuring the safety, reliability, and compliance of elevators. This position involves conducting thorough inspections, testing mechanical and electrical components, and verifying adherence to local, state, and federal safety codes and regulations. The inspector will identify potential hazards, document findings, and recommend necessary repairs or maintenance to prevent accidents and ensure optimal operation. Ultimately, the Elevator Inspector helps protect the well-being of building occupants and the general public by enforcing rigorous safety standards and promoting best practices in elevator operation and maintenance. Minimum Qualifications: • High school diploma or equivalent., • Must possess a valid license through the NJ Department of Community of Affairs, • Subcode license and/or experience, • Experience working in elevator maintenance, repair, or installation., • Familiarity with computerized inspection reporting systems and mobile inspection technology., • Certification in additional safety or inspection programs, such as OSHA safety training., • Perform detailed inspections of elevators, escalators, and related equipment to assess mechanical, electrical, and structural integrity., • Test safety devices, control systems, and emergency operations to ensure compliance with applicable codes and standards., • Document inspection results accurately, prepare detailed reports, and communicate findings to building owners and maintenance teams., • Identify violations or safety hazards and provide clear recommendations for corrective actions or repairs., • Stay current with evolving safety regulations, industry standards, and technological advancements related to vertical transportation systems., • Coordinate with regulatory authorities to facilitate certification and compliance processes. The required skills enable the Elevator Inspector to conduct precise and comprehensive evaluations of elevator systems, ensuring all components meet stringent safety criteria. Technical proficiency in reading schematics and understanding mechanical and electrical systems is essential for identifying potential issues during inspections. Strong analytical skills help in diagnosing problems and determining the root causes of malfunctions or code violations. Effective communication skills are used daily to clearly document findings, explain safety concerns, and collaborate with building owners and maintenance personnel to implement solutions. Preferred skills, such as experience with digital reporting tools and advanced certifications, enhance efficiency and accuracy in inspections, while also supporting ongoing professional development and adherence to best industry practices.

Job Description ABOUT ORGANOX: OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. About the Role We are seeking a dynamic Product Manager, Downstream to drive the commercial success and market adoption of the OrganOx metra, normothermic perfusion platform. This role is focused on translating complex clinical and economic data into compelling messaging and tools that resonate with customers, support the sales team, and ensure top-line growth. You will become the clinical and functional expert on the metra, working closely with sales, clinical affairs, and key customers to shape market perception and drive share growth. The role will require development of customer and field facing strategies, market research to understand market trends and customer insights, clinical evidence strategy, and support of continuation marketing activities. To gain deep clinical and technical product knowledge the Product Manager, Downstream will be expected to spend time with customers and sales team regularly. This person will also work closely with cross-functional partners across the organization and should have the ability to lead and work with a diverse range of partners and on multiple parallel projects. Requirements • Commercialization & Go-to-Market: Lead end-to-end launch planning and execution for new products and existing product updates across global markets, ensuring operational readiness of supply chain, manufacturing, and sales., • Product Positioning & Messaging: Develop and refine product positioning, value proposition, and messaging tailored to specific customer segments (e.g., transplant physicians, hospital and transplant service line administration, patients, patient advocacy groups) and regional markets., • Sales Enablement and Training: Develop high-impact sales tools, training materials, and programs to equip field teams with the resources needed to elevate customer conversations and overcome objections., • Clinical and Economic Evidence Communication: Translate complex clinical study data and economic evidence into clear, compelling stories and tools that demonstrate the product's differentiated value and link outcomes, cost, and long-term clinical benefit., • Market and Competitive Intelligence: Monitor market dynamics, track competitor activity, and gather customer feedback to inform marketing strategies and develop comprehensive competitive response plans., • Stakeholder and KOL Engagement: Build and maintain strong relationships with Key Opinion Leaders (KOLs) and customers through field visits, scientific meetings, and educational programs to gain insights and drive market adoption. · Education: Bachelor's degree required; MBA or advanced degree preferred. · Experience: Minimum 3 years of experience in product management or marketing within the medical device industry, with a strong emphasis on downstream or commercial marketing. · Clinical Knowledge: Ability to gain deep clinical and technical product knowledge and serve as a subject matter expert to internal and external stakeholders. · Communication Skills: Excellent interpersonal, written, verbal, and presentation skills, with proven experience presenting to senior leadership and external customers. · Cross-functional Collaboration: Demonstrated success working as an integral cross-functional team member, capable of influencing without direct authority. Experience with regulatory approval processes for medical device systems, including electronics and software. · Analytical Skills: Strong analytical and data interpretation skills to track performance, analyze sales trends, and make data-driven decisions. Proven ability to collaborate with commercial and finance teams to define and implement effective business models. · Travel: Ability to travel up to 25-30% of the time, including field visits and industry events. · Preferred Qualifications · Direct experience with medical devices or pharmaceuticals supporting the transplant market. · Proven track record in launching products into new or existing markets. Benefits We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Job DescriptionJob Summary: The Director of Regulatory Affairs is responsible for executing the company’s regulatory strategy across the development and commercial product portfolio. This role reports to the Senior Vice President, Regulatory Affairs. This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. As a leader in the organization, this role oversees the management of day-to-day operations of the regulatory affairs function. This includes management and maintenance of open regulatory applications (INDs and NDAs) with an emphasis on high-quality, timely submissions to Regulatory Agencies (primarily FDA). Submissions include IND's and NDA's (including 505(b)(2)), Annual Reports, amendments, Clinical Trial Applications, IND/NDA supplements, expedited program designation requests, and Pediatric Study Plans. Lastly, this role will coordinate, guide, and oversee global health authority interactions and regulatory submissions with the support of partners and regional vendors. Responsibilities: • Executes the defined regulatory strategy across the product portfolio., • Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives., • Represents Regulatory Affairs within project teams and provides regulatory guidance to R&D, Clinical, Quality and Operations teams, as appropriate., • Provides guidance to teams and peers to solve problems, achieve goals and meet company defined timelines., • Provides clear communications of regulatory risk(s) associated with development activities., • Provides regulatory guidance and recommendations in support of company goals., • Must exercise judgment within defined procedures and policies to determine appropriate regulatory direction and communicate to, • Serves as primary point of contact with FDA project manager for assigned projects., • With minimal supervision, leads the preparation of responses to Health Authorities (US and Global)., • Liaises and orchestrates meetings with cross functional, • Participates in product team meetings (development and marketed products)., • Ensures product team activities align with defined regulatory strategy, • Reviews technical documents for submission in new INDs, NDAs and provides guidance to the technical development, • Authors and prepares original INDs/NDAs and amendments for submission to Regulatory, • Manages day-to-day regulatory activities for assigned projects., • Prepares both major and routine submissions to regulatory applications. Qualifications: • Minimum of a bachelor’s degree in a science-related discipline; RAC certification is a, • Global regulatory experience in ICH regions and Canada is a plus., • 10 to 15 years of relevant regulatory experience in pharmaceutical pharmaceutical/biotechnology experience, with extensive knowledge of all aspects of the drug development, • Must demonstrate recognized leadership qualities in previous roles., • Strong project management skills is a plus., • Strong knowledge of current US and global regulations/gui, • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations team, • Proven ability to communicate with executive management and external thought leaders., • Demonstrated identification of key regulatory risks., • Must be well organized, detail-oriented, and can multi-task and manage changing priori The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary. As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Please Note: Aquestive is a drug-free workplace and has a drug free workplace policy in place. Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. About the Role The Manager, Government Affairs plays a critical role in shaping and advancing the organization's public policy objectives by engaging with government officials, regulatory agencies, and key stakeholders. This position is responsible for monitoring legislative and regulatory developments, analyzing their potential impact, and developing strategic responses to influence policy outcomes favorably. The role requires building and maintaining strong relationships with policymakers and industry groups to advocate effectively on behalf of the organization. The Manager will lead efforts to communicate the organization's positions clearly and persuasively, ensuring alignment with overall business goals. Ultimately, this role drives the organization's ability to navigate complex political environments and secure a competitive advantage through proactive government engagement. Essential Duties • Monitor and analyze federal, state, and local legislative and regulatory activities relevant to the organization's interests., • Develop and implement government affairs strategies that support the organization's business objectives and compliance requirements., • Build and maintain relationships with elected officials, government agencies, industry associations, and other stakeholders., • Prepare briefing materials, position papers, and testimony to effectively communicate the organization's policy positions., • Coordinate with internal teams to align government affairs initiatives with corporate strategy and operational priorities., • Represent the organization at public hearings, industry forums, and coalition meetings to advocate for favorable policy outcomes., • Proficiency with Quality system applications (e.g., eDMS, QMS), • Dedicated team player who is able to withstand the high demands of a fast-paced environment., • Results driven, problem solver, and collaborator Excellent written and verbal communication skills, • Excellent planning and time management skills and the ability to handle several tasks simultaneously., • Comfortable working independently with minimal supervision, • Ability for travel up to 20% of the time, • Must be able to provide clear direction while motivating teams., • At least 5 years of experience in government affairs, public policy, or legislative advocacy., • Master’s degree in Public Administration, Public Policy, Law, or related discipline., • Experience working within or closely with the private sector in a regulated industry., • Familiarity with lobbying compliance and ethics regulations., • Established network of contacts within government agencies and legislative bodies. Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $100,000 to $150,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

At least 10-12 years of progressive experience in pharmaceutical regulatory affairs; expert knowledge of cGMP is required. Regulatory Affairs Director to lead our complex portfolio, including Biosimilars (351(k)) and 505(b)(2) innovative products. Lead the development of innovative regulatory strat

Regulatory Affairs Specialist III. Preparing, compiling, reviewing and processing the regulatory submissions document.

The Regulatory Affairs (RA) Specialist is responsible for supporting global regulatory submissions and compliance activities to ensure medical device products meet applicable regulatory requirements throughout their lifecycle. Solid understanding of scientific principles applied to regulatory affair

Qualifications Education Qualifications Bachelor's Degree Life Science Degree required Master's Degree preferred PharmD preferred Experience Qualifications 7 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields required Experience in Digital Transf

Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissions In collaboration with CDx lead work with Dx partners to ensure robust development of assay, participate in HA interaction for drug-related C

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

Ensure guest charts are up to date, consistent with policy and meets the DMHS regulatory guidelines.

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

The Regional Executive Director ensures all aspects of clinical care and programming are aligned with evidence based, best practices, and complies with all applicable legal, ethical, and regulatory standards. Compliance with all applicable laws and regulatory standards. Knowledge of relevant legal,

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

Competitive pay / Medical, dental & vision / 401k / PTO - As a Customer Service Rep at Planet Home Lending, you will: Respond to borrower inbound calls concerning their account, ensuring high quality service and adhering to productivity and regulatory requirements; Research customer issues and work

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl

DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day.As a Dasher, you’ll stay busy with a variety of earnings opportunities and can work when it works for you.Whether you’re looking for a side hustl