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If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit ___ for more information. Brief Description: The Director of Real-World Evidence (RWE) will provide (scientific/strategic/tactical/etc) leadership for RWE studies and analyses using administrative claims data/EMR, reporting to the Head of RWE. The Director of RWE will function on an analytics team responsible for establishing rigorous assessments of administrative claims data/EMR to evaluate real-world outcomes for all Jazz products. The incumbent will provide exceptional leadership for projects under his/her direct responsibility and oversee the tactical planning and execution of RWE projects conducted by RWE analytic team or external vendors. The candidate will also ensure the timeliness and delivery of scientifically valid research. Essential Functions/Responsibilities * Develop RWE strategies for one or multiple molecules, in collaboration with internal partners, to ensure that the value of Jazz products is fully supported by evidence for global and regional audiences. * Drive RWE innovations and effective communication with internal stakeholders, regulatory bodies, health technology assessment bodies, and scientific communities; continuously strive to publish results in peer-reviewed journals and conferences. * Lead the design and execution of RWE research projects using administrative claims data/ EMR, including the development of protocols and contributions to statistical analysis plans (SAPs). * Responsible for RWE leadership across internal cross-functional teams. Leverage advanced communication and translation skills and strategic planning across health economics and outcomes research, medical affairs, and clinical development functions. * Support the Evidence & Value Generation (EVG) department in developing and implementing operational processes related to daily RWE activities for internal departments. * Assess real-world data assets and establish data curation plans, including provisioning data licenses and platforms, in collaboration with the EVG leadership team. * Stay current with research on RWE methodology and its applications as pertinent to project needs. Required Knowledge, Skills, and Abilities * Familiarity with the US and global health care delivery system (e.g., payers and reimbursement models) * Experience in designing, collecting, and analyzing RWD/RWE using administrative claims datasets, EMRs, and patient charts * Strong analytical skills and ability to work with multi-disciplinary teams required to support program, project, and contract management and financial reporting * Experience with big data analytical platforms * A track record of peer-reviewed scientific publications demonstrating expertise in RWE * Demonstrated strategic and conceptual skills to develop innovative approaches for developing product differentiation Required/Preferred Education and Licenses * PhD in epidemiology or related discipline with 8+ years of research experience * At least 3 years with analytic experience of healthcare claims databases/EMR within the biopharmaceutical industry or provider/payer organizations Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $196,000.00 - $294,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: ___.

If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit ___ for more information. The Associate Director (AD) of Real-World Evidence (RWE) will provide (scientific/strategic/tactical/etc) support on RWE studies and analyses using administrative claims data/EMR, reporting to the Head of RWE. The AD of RWE will function on an analytics team responsible for establishing rigorous assessments of administrative claims data/EMR to evaluate real-world outcomes for all Jazz products. The incumbent will provide exceptional leadership for projects under his/her direct responsibility and oversee the tactical planning and execution of RWE projects conducted by RWE analytic team or external vendors. The candidate will also ensure the timeliness and delivery of scientifically valid research. Essential Functions/Responsibilities • Support the development of RWE strategies for one or multiple molecules, in collaboration with internal partners, to ensure that the value of Jazz products is fully supported by evidence for global and regional audiences., • Lead the design and execution of RWE research projects using administrative claims data/ EMR, including the development of protocols and contributions to statistical analysis plans (SAPs)., • Drive RWE innovations and effective communication with internal stakeholders, regulatory bodies, health technology assessment bodies, and scientific communities; continuously strive to publish results in peer-reviewed journals and conferences., • Responsible for RWE leadership across internal cross-functional teams. Leverage advanced communication and translation skills and strategic planning across health economics and outcomes research, medical affairs, and clinical development functions., • Support the Evidence & Value Generation (EVG) department in developing and implementing operational processes related to daily RWE activities for internal departments., • Assess real-world data assets and establish data curation plans, including provisioning data licenses and platforms, in collaboration with the EVG leadership team., • Stay current with research on RWE methodology and its applications as pertinent to project needs., • Familiarity with the US and global health care delivery system (e.g., payers and reimbursement models), • Experience in designing, collecting, and analyzing RWD/RWE using administrative claims datasets, EMRs, and patient charts, • Strong analytical skills and ability to work with multi-disciplinary teams required to support program, project, and contract management and financial reporting, • Experience with big data analytical platforms, • A track record of peer-reviewed scientific publications demonstrating expertise in RWE, • Demonstrated strategic and conceptual skills to develop innovative approaches for developing product differentiation, • PhD in epidemiology or related discipline with 5+ years of research experience or MS in epidemiology with 8+ years research experience FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $164,000.00 - $246,000.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: ___.

An opportunity has arisen in our Cambridge based Regulatory and Medical Affairs team for a Regulatory Affairs Manager. Our Regulatory and Medical Affairs team is responsible for ensuring that OGTs products are safe, effective, and fit for purpose, thus allowing them to be available globally and stat

An opportunity has arisen in our Cambridge based Regulatory and Medical Affairs team for a Regulatory Affairs.

Senior Regulatory Affairs Associate - Pharmaceutical. Taking the lead on labelling and artwork for the US portfolio of products – ensuring timely production, accurate presentation and compliance of regulatory information. Lead the promotional material submission process to the FDA, prepare lab

The ideal candidate will act as the key liaison between the business, its products, and regulatory bodies, with responsibility across pre- and post-market regulatory activities. Provide regulatory guidance to internal teams and senior management, supporting the preparation and submission of regulato

Associate Director – Regulatory Affairs (IVD) | Cambridge Hartmann Young is partnered with an innovative and fast-growing diagnostics company based in Cambridge. We’re seeking a proactive and experienced Associate Director of Regulatory Affairs to lead global regulatory strategy across a portfolio of pioneering IVD technologies. This is a high-impact, hands-on leadership role supporting both FDA and IVDR pathways, ideal for someone who thrives in a collaborative, cross-functional environment. You’ll work closely with R&D, Clinical, Quality, and Operations teams to bring impactful diagnostic solutions to global markets — from early development through to registration and post-market compliance. Key Requirements: • Proven experience in regulatory affairs within the IVD, diagnostics, or medical device sectors, • Demonstrated success with FDA submissions (e.g., 510(k), Pre-Subs), • Strong working knowledge of EU IVDR and technical documentation requirements, • Skilled at interpreting complex regulatory requirements and translating them into actionable strategies, • Confident liaison with regulatory authorities and notified bodies, • Collaborative mindset, comfortable working across functions and influencing senior stakeholders, • Able to manage multiple regulatory projects and priorities in a fast-paced setting, • Detail-oriented, analytical, and highly organised Desirable Experience: • Leadership of regulatory strategy from development through post-market, • Experience working in small-to-mid-sized or scaling life sciences companies, • Familiarity with companion diagnostics, point-of-care, or molecular platforms Location: Cambridge (Hybrid – 3 days/week in-office) - REQUIRED Please apply directly or reach out to for more information.

Regulatory Affairs professionals with 5+ years of experience. Experienced Regulatory Affairs Professionals – Manager to Director Level. We’re hiring experienced Regulatory Affairs professionals (Manager to Director level) with deep expertise in Accelerated Market Access (AMA) and Clinical Trial

Maintain awareness of current regulatory requirements and precedents in the CMC regulatory landscape. As a Senior Specialist in Regulatory Affairs CMC, you are responsible for supporting the development and tracking of high-quality regulatory CMC and device documentation in alignment with MoonLake��

Extensive experience leading development of end to end labeling process regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional leaders and teams for multiple medicinal products. Regulatory Affairs Labeling Execution

An opportunity has arisen in our Cambridge based Regulatory and Medical Affairs team for a Regulatory Affairs Manager. Holds a recognised qualification in Regulatory Affairs. Our Regulatory and Medical Affairs team is responsible for ensuring that OGT’s products are safe, effective, and fit for pu

Executive Director, Head of Medical Affairs - Airways Disease. Collaborate across global medical functions and with the Global Product Team (commercial, R&D, regulatory, biostatistics, etc. Strategic and medical leadership skills.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to advancements across our robust pipeline of innovative therapeutics in oncology and laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Brief Description: The Associate Director (AD) of Real-World Evidence (RWE) will provide (scientific/strategic/tactical/etc) support on RWE studies and analyses using administrative claims data/EMR, reporting to the Head of RWE. The AD of RWE will function on an analytics team responsible for establishing rigorous assessments of administrative claims data/EMR to evaluate real-world outcomes for all Jazz products. The incumbent will provide exceptional leadership for projects under his/her direct responsibility and oversee the tactical planning and execution of RWE projects conducted by RWE analytic team or external vendors. Lead the design and execution of RWE research projects using administrative claims data/ EMR, including the development of protocols and contributions to statistical analysis plans (SAPs). Drive RWE innovations and effective communication with internal stakeholders, regulatory bodies, health technology assessment bodies, and scientific communities; Leverage advanced communication and translation skills and strategic planning across health economics and outcomes research, medical affairs, and clinical development functions. Assess real-world data assets and establish data curation plans, including provisioning data licenses and platforms, in collaboration with the EVG leadership team. Stay current with research on RWE methodology and its applications as pertinent to project needs. Experience in designing, collecting, and analyzing RWD/RWE using administrative claims datasets, EMRs, and patient charts Strong analytical skills and ability to work with multi-disciplinary teams required to support program, project, and contract management and financial reporting Experience with big data analytical platforms A track record of peer-reviewed scientific publications demonstrating expertise in RWE PhD in epidemiology or related discipline with 5+ years of research experience or MS in epidemiology with 8+ years research experience At least 2 years with analytic experience of healthcare claims databases/EMR within the biopharmaceutical industry or provider/payer organizations Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. Remote working/work at home options are available for this role.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to advancements across our robust pipeline of innovative therapeutics in oncology and laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Brief Description: The Associate Director (AD) of Real-World Evidence (RWE) will provide (scientific/strategic/tactical/etc) support on RWE studies and analyses using administrative claims data/EMR, reporting to the Head of RWE. The AD of RWE will function on an analytics team responsible for establishing rigorous assessments of administrative claims data/EMR to evaluate real-world outcomes for all Jazz products. The incumbent will provide exceptional leadership for projects under his/her direct responsibility and oversee the tactical planning and execution of RWE projects conducted by RWE analytic team or external vendors. Lead the design and execution of RWE research projects using administrative claims data/ EMR, including the development of protocols and contributions to statistical analysis plans (SAPs). Drive RWE innovations and effective communication with internal stakeholders, regulatory bodies, health technology assessment bodies, and scientific communities; Leverage advanced communication and translation skills and strategic planning across health economics and outcomes research, medical affairs, and clinical development functions. Assess real-world data assets and establish data curation plans, including provisioning data licenses and platforms, in collaboration with the EVG leadership team. Stay current with research on RWE methodology and its applications as pertinent to project needs. Experience in designing, collecting, and analyzing RWD/RWE using administrative claims datasets, EMRs, and patient charts Strong analytical skills and ability to work with multi-disciplinary teams required to support program, project, and contract management and financial reporting Experience with big data analytical platforms A track record of peer-reviewed scientific publications demonstrating expertise in RWE PhD in epidemiology or related discipline with 5+ years of research experience or MS in epidemiology with 8+ years research experience At least 2 years with analytic experience of healthcare claims databases/EMR within the biopharmaceutical industry or provider/payer organizations Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. Remote working/work at home options are available for this role.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to advancements across our robust pipeline of innovative therapeutics in oncology and laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Brief Description: The Associate Director (AD) of Real-World Evidence (RWE) will provide (scientific/strategic/tactical/etc) support on RWE studies and analyses using administrative claims data/EMR, reporting to the Head of RWE. The AD of RWE will function on an analytics team responsible for establishing rigorous assessments of administrative claims data/EMR to evaluate real-world outcomes for all Jazz products. The incumbent will provide exceptional leadership for projects under his/her direct responsibility and oversee the tactical planning and execution of RWE projects conducted by RWE analytic team or external vendors. Lead the design and execution of RWE research projects using administrative claims data/ EMR, including the development of protocols and contributions to statistical analysis plans (SAPs). Drive RWE innovations and effective communication with internal stakeholders, regulatory bodies, health technology assessment bodies, and scientific communities; Leverage advanced communication and translation skills and strategic planning across health economics and outcomes research, medical affairs, and clinical development functions. Assess real-world data assets and establish data curation plans, including provisioning data licenses and platforms, in collaboration with the EVG leadership team. Stay current with research on RWE methodology and its applications as pertinent to project needs. Experience in designing, collecting, and analyzing RWD/RWE using administrative claims datasets, EMRs, and patient charts Strong analytical skills and ability to work with multi-disciplinary teams required to support program, project, and contract management and financial reporting Experience with big data analytical platforms A track record of peer-reviewed scientific publications demonstrating expertise in RWE PhD in epidemiology or related discipline with 5+ years of research experience or MS in epidemiology with 8+ years research experience At least 2 years with analytic experience of healthcare claims databases/EMR within the biopharmaceutical industry or provider/payer organizations Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. Remote working/work at home options are available for this role.

Regulatory Affairs Manager – Oncology Cell Therapy. Represents the Regulatory Affairs function in cross functional teams to ensure optimal execution of the agreed regulatory strategy for both approved and development ATMPs. Interacts with the Global Regulatory Lead to agree and ensures delivery of

Regulatory Affairs Project Manager | Senior Regulatory Affairs Specialist | Regulatory Affairs Manager | Senior Regulatory Affairs Officer | Pharmaceutical | Labelling | Artwork. As the Regulatory Affairs Project Manager, you will partner with cross-functional teams to deliver compliant, high-qualit

Maintain awareness of current regulatory requirements and precedents in the CMC regulatory landscape. As a Senior Specialist in Regulatory Affairs CMC, you are responsible for supporting the development and tracking of high-quality regulatory CMC and device documentation in alignment with MoonLake's

Newton Colmore Consulting is a specialised recruitment company operating in the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Data Science, Healthcare Communications, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance, and

Job Description OGT is a leading global provider of clinical and diagnostic genomic solutions.We believe in creating products and partnerships that enable clinicians to deliver personalised healthcare to patients and that empower clinical researchers to develop the next generation of precision medi

An opportunity has arisen in our Cambridge based Regulatory and Medical Affairs team for a Regulatory Affairs.

You will be responsible for the strategy and oversight of the regulatory information management system (RIM) and oversight of the regulatory systems support group and regulatory submission management and publishing teams. Regulatory Affairs Systems and Data Manager. You will also be responsible for

Liberty Global is a world leader in converged broadband, video and mobile communications and an active investor in cutting-edge infrastructure, content and technology ventures. Liberty Global Ventures, our global investment arm, has a portfolio of more than 75 companies and funds across content, tec

The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA. Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager. This position is part

Are you an experienced regulatory affairs professional with deep expertise in Chemistry, Manufacturing, and Controls (CMC)? We’re looking for a Senior Manager to join a dynamic Medicine Development team supporting multiple projects from development through post-approval stages. Proven track record

Are you an experienced Regulatory Affairs Manager looking to make a impact in the chemical manufacturing industry? We are seeking a proactive and detail-oriented professional to lead the regulatory strategy and ensure full compliance across site operations. As a Regulatory Affairs Manager , you will

Manage external regulatory service providers to align with business objectives and support the development and maintenance of an effective regulatory affairs function. Demonstrated success in regulatory strategy development, multi-project leadership, and managing high-level regulatory authority inte

UmbrellaRegulatory Affairs Consultant Role: The Regulatory Affairs Consultant EMEA (Self Care) is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product develo

Do you have a proven regulatory affairs background from within the Pharmaceutical space, and want to bring your creative side into play too?. Senior Regulatory Affairs Associate - Pharmaceutical. Taking the lead on labelling and artwork for the US portfolio of products – ensuring timely production

Umbrella Regulatory Publishing Assistant Role: - Support publishing activities, ensuring accuracy and timely completion to challenging deadlines- Collaborate with team members to ensure successful delivery of the portfolio- Assist in the future delivery of innovative solutions, ensuring seamless i

Associate Director – Regulatory Affairs (IVD) | Cambridge. Associate Director of Regulatory Affairs. Skilled at interpreting complex regulatory requirements and translating them into actionable strategies.

Minimum of 3-5 years’ experience in regulatory affairs within the medical device industry. Senior Regulatory Affairs Specialist. The successful candidate will play a critical role in ensuring compliance with global regulatory requirements, leading technical file preparation, regulatory approvals,

Planet Pharma is seeking a highly skilled regulatory affairs candidate with strong Chemistry, Manufacturing, and Controls (CMC) experience, particularly in preparing documentation for both Clinical Trial Applications (CTAs) and Marketing Authorization Applications (MAAs). Proven experience in CMC re

Develop junior talent within the Regulatory Affairs function, building capability and ensuring best practice. IVD and/or medical device regulatory affairs, ideally with EU focus. Recognised qualification in Regulatory Affairs and evidence of CPD.

Direct experience preferred in providing strategic regulatory planning from early-stage development up to marketing authorisation, and a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues. Scendea is an international product d

As a Senior Specialist in Regulatory Affairs CMC, you are responsible for supporting the development and tracking of high-quality regulatory CMC and device documentation in alignment with MoonLake’s development programs, working closely with Technical Operations colleagues. Prepare, edit, and fina

Regulatory Affairs CMC Senior Manager. Must have previous experience authoring Regulatory CMC sections for EU/US submissions. The role will be working across both portfolios and will have a heavy focus on regulatory strategy.

Role: Principal Regulatory Specialist. A global company is seeking to expand its regulatory team and is looking for a talented individual to join. Experience evaluating manufacturing changes for impact on global regulatory submissions.

This position will contribute to the build-out of the regulatory affairs function at Edgewise and will provide regulatory expertise from preclinical through clinical development for our programs. Associate Director / Director, Regulatory Affairs (EU- or UK-based). Responsible for regulatory clinical

Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. The Principal Regulatory Affairs Specialist will provide expert level regulatory support and direction to products from concept to launch, and beyond into po

As the Senior Regulatory Affairs Director you will be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. You will partner with marketing company and regional regulatory affairs staff to influence deve

The Regulatory Affairs Senior Manager provides regional (EU and other ex-US countries) support for all regulatory activities related to the ongoing development and life-cycle management of imetelstat (Rytelo) and future development product candidates. The Senior Manager will interact closely with co

The Principal Regulatory Affairs Specialist will provide expert level regulatory support and direction to products from concept to launch, and beyond into post market, as well as regulatory processes. Supports Regulatory Affairs Project core team members on development teams, providing regulatory gu

Lead and manage CMC-regulatory activities across various development and marketed products, ensuring compliance and regulatory risk mitigation. Develop and execute CMC-regulatory strategies and oversee the preparation of key regulatory documents, including Module 3 sections. Proven track record in C

Regulatory Affairs Manager Clinical Trials. As we expand our footprint to Warsaw, Poland, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services. Together, we can shape the future of regulatory solutions.

Management and leadership of a team of Financial Planners.Direct line management of the Head of Paraplanning, ensuring the paraplanning function is effectively supporting the adviser team.Player/Manager" - Enjoy dealing with clients and continuing managing client relationships and writing new busine

This includes developing the vision for and responsible for overall leadership and strategic direction of the Regulatory Affairs team to ensure licenses are obtained in a timely manner in line with business strategy and the business markets products with consistently high quality, safety and efficac

Project Management Course Programme Job Guarantee Included Complete online training designed to take you from zero experience to your first project management role.Study part-time, build fundamental skills, and get dedicated job placement support until you're hired.Flexible financing options availa