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Regulatory HOW MIGHT YOU DEFY IMAGINATION If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us. REGULATORY AFFAIRS MANAGER LIVE What you will do In this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products. You will support one or more products from a regional regulatory perspective. Strategy and Execution • Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgens portfolio in compliance with global filing plans and local regulatory requirements., • Under general supervision implement product related regulatory strategies Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements., • Provide content guidance for regional regulatory documents and meetings in accordance with global strategy, • Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies Orphan Drug Fast Track compassionate use and paediatric plans), • Support regional label negotiation activities, • Under general supervision participate in the development and execution of regional regulatory product strategies, • Under general supervision develop predictions for expectations and risks associated with outcomes by regulatory agencies Regulatory Research • Maintain an awareness of new and developing legislation regulatory policy and technical Regulatory guidance relating to Amgen products., • Perform regulatory research to obtain relevant histories precedence and other information relevant to regional product advancement., • Under supervision evaluate and communicate impact of relevant regional regulations guidances current regulatory environment and competitor labelling Be part of our team You will be joining the European General Medicine Regulatory team part of the Global Regulatory Affairs function in Europe. You will be working with colleagues who are responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation and throughout the products lifecycle. This team leads the regulatory activities for established products and also development assets in the Metabolic Cardiology Inflamation Endocrine and Bone disease areas as well as pre-approval filing activities for Biosimilars. WIN What we expect of you We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills: • Scientific Degree and demonstrated experience in a similar role, • Regulatory principles, • Working with policies procedures and SOPs, • Knowledge of legislation and regulations relating to medicinal products, • Awareness of the registration procedures in region for clinical trials MA post approval changes extensions and renewals., • Knowledge of drug development, • Knowledge of and experience in regional regulatory environment, • Strong communication skills - both oral and written, • Ability to understand and communicate scientific/clinical information, • Ability to anticipate and prevent potential issues, • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome THRIVE What you can expect of us As we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being. • Growth opportunities to learn and move up and across our global organization, • Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act, • Generous Total Rewards Plan comprising health finance and wealth work/life balance and career benefits LOCATION: Flexibility to work from home with few days per month working from our Cambridge or Uxbridge office. APPLY NOW for a career that defies imagination In our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race colour religion sex sexual orientation gender identity national origin protected veteran status or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation. . Required Experience: Manager Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1

Description Videographer Location: Cambridge UK (this role is office-based) Salary: p.a. full-time equivalent dependent on experience Basis: Permanent; full-time Eligibility: You must be eligible to work in the UK The role Were looking for a skilled Videographer as part of the media team within the Comms and Marketing team at the Raspberry Pi Foundation in Cambridge. This is a great opportunity for a creative storyteller to join our growing and ambitious in-house team to help us share learning experiences resources and community voices in computing with a global audience through video and podcasts. In this role you will plan and execute high-quality educational video and podcast content across the Foundation. You will focus on our online courses podcasts for teachers and bringing our impact to life with stories from our amazing community. Our videos are a mixture of full-length content and creative edits for marketing and social media. You will be responsible for filming and editing including setting up camera lighting and audio equipment and delivering edits that meet our brand guidelines and accessibility standards. You will also support the pre-production processes advising on timings scripting and storyboard development. Youll have experience of filming video production and editing across different kinds of content. Youll be passionate about video and design and enjoy trying new ideas. Youll be able to take direction and to work within our established visual style but also have the confidence and experience to propose new ideas. Youll have a good knowledge of trends in the video industry and social media and be able to apply this to your work. Youll be a highly collaborative person and have an eye for detail. This new role will strengthen the team to help us reach more people and make full use of our custom-built new media studio which includes a dedicated space for video and podcast recording.. We strive to make the Foundation a place where talented people who care about our mission can do the best work of their careers. We have a flexible and collaborative approach to all aspects of our work. If youre the right person for the job well make it work for you and you can be confident that youll be working with an exceptional team. Responsibilities • Plan and execute engaging video content that supports teachers and learners around the world, • Project-manage all aspects of video production and editing for course and lesson materials, • Support the Communications and Marketing team on wider promotional activities including edits for social media developing case study films and filming on location at events, • Provide consultation and expertise in the pre-production phase such as idea generation storyboarding and visual aspects, • Conduct on-location shoots including managing logistics directing talent and capturing B-roll footage as needed, • Set up and operate camera equipment lighting and audio devices for video shoots within the office studio or on location ensuring high-quality footage and sound, • Edit video footage within Adobe Creative Cloud (Adobe Premiere Pro After Effects Illustrator), • Design and integrate captivating motion graphics to enhance video content ensuring visual consistency and engaging storytelling, • Develop and build video templates to streamline production processes maintaining brand identity and visual consistency across all projects for other creatives, • Execute small animation projects bringing creative concepts to life through engaging visuals and dynamic motion We recognise that everyone has the potential for growth and we welcome applications from candidates who can demonstrate that they have some but not all of the experience and personal attributes listed here. • Proven experience as a self-shooting videographer with a strong portfolio showcasing your work, • Proficiency in studio setup and operation including knowledge of lighting techniques camera angles and audio recording in a controlled environment, • Excellent attention to detail and ability to maintain high-quality standards in all aspects of video production, • Excellent knowledge of Adobe Premiere Pro After Effects and Illustrator editing a variety of styles of content from docs to online courses to short social videos, • Good experience in designing captivating motion graphics/principles including timing easing and keyframe animation to produce fluid and engaging motion graphics, • Ability to manage multiple projects simultaneously and work to deadlines, • Strong experience of working with presenters including pre-shoot preparation run throughs and maintaining a calm environment during shoots, • Solution-driven creative thinking and problem-solving skills to overcome challenges during production, • Excellent communication skills and ability to collaborate effectively with team members and stakeholders, • Expertise in post-production techniques for enhancing and optimising video quality refining and improving lesser AV to achieve professional standards, • Proficient in macOS environment We empower schools to teach computer science and AI literacy through free curricula classroom resources purpose built software tools and professional development for teachers. We inspire young people to become tech creators through the worlds largest networks of coding clubs. We undertake original research that informs our work and which we use to advance the field of computer science education more broadly. All of our resources and learning experiences are available for anyone to use at no cost. We are particularly focused on creating opportunities for young people who experience educational disadvantage and those who come from backgrounds traditionally underrepresented in technology industries. Over the past decade we have supported hundreds of thousands of educators and tens of millions of students. We have teams in six countries (India Ireland Kenya South Africa the UK and US) and partnerships with mission-aligned non-profit organisations in over 60 countries. We are at the forefront of the global educational movement to expand access to computer science education and AI literacy. You can learn more about our work in our latest Annual Report. Benefits In addition to competitive salaries we offer a wide range of benefits for all of our colleagues. • Paid time off. In addition to public holidays full-time employees in the UK receive 25 days of paid annual leave initially rising to 30 days after five years service plus 3 additional days of paid leave for the company-wide closure at the end of each year., • Pension. We provide an 8% employer contribution on top of your minimum 4% employee contribution., • Private healthcare. We provide comprehensive private healthcare for all employees through Vitality Plus., • Flexible working. We have clear policies to provide flexibility over when and where you work helping you balance work responsibilities with the rest of your life., • Support for parents and carers. We provide generous family leave and flexibility for parents and carers., • Life assurance and income protection. We provide life assurance and income protection schemes to provide peace of mind for you and your family., • Investing in learning and development. We invest in your growth and development including through access to learning resources and training with dedicated time for all employees. Our recruitment process All of our workplaces are inclusive spaces where we want people to feel respected valued and able to do their best work. We are committed to building teams that bring together people with a broad range of backgrounds skills and perspectives. That starts with our recruitment process. Heres what you can expect: • As part of your application you will be asked to respond to a small number of questions that we will use to screen your eligibility for the role. You will also be asked to provide your cv and a short cover letter., • Eligible applications will be reviewed by our recruitment team and the hiring manager., • A small number of candidates will be invited to a phone call with the hiring manager., • The purpose of this call is to check our understanding of your application and to answer any questions you have., • We normally have two interviews at least one of which will take place in-person. Interviews will be with the hiring manager and at least one other colleague., • You will usually be asked to undertake a work-based assessment in advance of your interviews. This will be an opportunity for you to show how you would perform some part of the role. You will be given advance notice and clear instructions. Key Skills Photography,Video Editing,Lighting Design,Adobe After Effects,Filming,Adobe Creative Suite,Adobe Photoshop,Adobe Illustrator,Adobe Lightroom,Adobe Premiere,Final Cut Pro,Video production Employment Type : Full Time Experience: years Vacancy: 1

Management of Regulatory Affairs personnel through line management and project delivery oversight. Responsible for developing study regulatory strategies and leading department initiatives. The role involves collaboration with other departments to support the successful approval of clinical trials. May have regional-specific responsibilities e.g. Manager Regulatory Affairs Europe. • Review study protocols and informed consent forms to ensure that documents are compliant with applicable regulatory standards and that regulatory and operational risks are minimized., • Manage and review the translation of drug labels in collaboration with sponsors and third-party vendors., • Support study regulatory strategy by:, • Management of regulatory aspects of the study ensuring required approvals are obtained, • Significant contribution to the achievement of study start-up milestones by overseeing and managing high quality regulatory submissions, • Monitor regulatory intelligences sources to ensure that the study remains in compliance throughout the lifecycle of the study, • Identify risks to milestone achievement and propose solutions to mitigate these risks, • Develop and author study Submission Management Plan, • Create and maintain study-specific regulatory trackers and document sharing methods to communicate information to internal and external stakeholders, • Act as first point of contact for all regulatory related communications with the sponsor and internal study team, • Organize and lead regulatory meetings with internal and external stakeholders and participate in cross-functional study team meetings ensuring that timely regulatory updates and issues are discussed, • Maintain efficient collaboration and relationship with external vendors responsible for study applications and oversee tasks delegated to them., • Prepare execute and/or oversee submissions as described in the Submission Management Plan including, • clinical trial applications to regulatory authorities and ethics committees and import/export license applications, • Develop and/or author country-specific Informed Consent Forms, • Perform Quality Check procedures on submissions documents and trackers, • Lead and coordinate responses to information requests from regulatory authorities or ethics committees, • Perform the above activities during study start-up and throughout the lifecycle of the clinical trial with, • amendments notifications annual reports and end of trial submissions ensuring compliance to ICH GCP regional/local requirements, • Problem solve and provide issue resolution to assist the team address unforeseen risks that have the potential to impact the successful delivery of the trial, • Support revenue recognition and other budget-related activities, • Represent the department during audits or inspections and address questions and issues raised by auditors or inspectors, • Mentor and train regulatory colleagues, • Main point of escalation for direct reports with Regulatory Study Lead responsibilities., • Oversee and provide guidance on all regulatory aspects of a study focusing on regulatory tracking issue management timelines and post-approval compliance (e.g. Annual Reporting Notifications)., • Perform Quality Check procedures on submissions documents and trackers, • Study revenue recognition and financial management/budget support., • Back-up and support direct reports with Regulatory Study and Country Lead responsibilities identified above., • Supervise mentor provide leadership and manage career and skill development of direct reports by supporting individual goals and objectives that align with department strategies and individual career ambitions and manage performance to ensure objectives are achieved., • Provide line management for assigned direct reports fostering an environment of curiosity flexibility empowerment accountability and transparency. Encourage a growth mindset., • Continuously gauge the pulse of direct reports and collaborate with other department leaders to evaluate department needs through training learning and development and other engagement-related improvements., • Identify and assess department needs and areas for improvement., • Lead initiatives that are aligned with department and organizational objectives., • Perform gap analyses in response to changing regulations and guidelines., • Initiate change management activities when new or revised regulations and guidelines impact business processes., • Subject matter expert for complex regulatory topics., • Review proposals and study pricing as required., • Participate in bid defenses as requested and when topics are included that align with areas of expertise., • 7 9 years of related experience, • (Honors) Bachelors degree, • Expert knowledge of European regulations across clinical and commercial phases, • Critical thinking and problem solving, • Managing Direct Reports, • Strong time management and organizational skills, • Financial and business acumen, • Difficult and complex communications (technical topics performance and team engagement), • Hands-on experience with regulatory submissions including and post-approval changes, • Skilled in regulatory project management tracking timelines deliverables and dependencies across global teams, • Regulatory intelligence and strategy able to interpret evolving guidelines and guide cross-functional teams accordingly, • Collaborative across functions works closely with clinical safety and medical writing teams, • Detail-oriented execution ensures accuracy compliance and consistency in all regulatory deliverables, • Strong communication and risk assessment skills capable of defending regulatory positions with internal/external stakeholders, • Home-based, • *Accommodations for job applicants with disabilities are available upon request.We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us. Required Experience: Manager Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference. Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together. Job Description FUNCTION: Global Therapeutic Area (TA) Regulatory Liaisons POSITION OVERVIEW: We are looking for a unique individual who is passionate about advancing therapeutics and thrives under pressure. This is an exciting opportunity for a Senior Manager to join the Gilead Virology Team. The future of the role encompasses providing regulatory strategy leadership and support as the Regional Regulatory Lead on the assigned products compounds indications or projects. With guidance defines the regulatory strategy plans and objectives for the assigned products or projects. You will lead the Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams. May serve as a Gilead contact to / for regulatory authorities. Manage oversee and coach less experienced colleagues. You will oversee and manage the work of less experienced colleagues supporting your work. You will coach and advise less experienced colleagues in completing their work and developing their regulatory capabilities. Typically assigned products compounds indications or projects of increasing complexity. May play a more active role in process improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams. JOB RESPONSIBILITIES: • Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional teams ( e.g. Study Management Clinical Nonclinical Biomarkers and/or cross-regional Regulatory Submission Teams., • With guidance defines the regulatory strategy for one or more Gilead products or projects (development or marketed products)., • Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans., • Leads the preparation compilation and timely filing of complex regulatory submissions which require cross-functional interactions for commercial or investigational product(s) for assigned territories in line with ICH requirements regional requirements and scientific and company policies and procedures. Examples include meeting requests briefing packages initial clinical trial applications/Amendments or routine submissions (e.g. Development Safety Update Reports / DSURs Investigator Brochure/ IB updates etc.) as well as post-approval submissions for marketed products., • Leads cross-functional teams in the authoring of regulatory documents and including meeting requests., • Responsible for ensuring regional product labelling is created and maintained in alignment with the Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI)., • Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets., • Critically reviews documents for submission to regulatory authorities., • Initiates or otherwise contributes to process improvements and/or other special projects within Regulatory Affairs., • Ensures own work complies with established practices policies and processes and any regulatory or other requirements. Education and/or Experience required • Life Science degree, • Extensive experience Regulatory Affairs or other relevant industry experience, • Experience setting the regulatory strategy and leading regulatory submissions and other activities for a medicinal product is strongly preferred., • In-depth knowledge of regulatory requirements including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs., • Good knowledge of regulatory requirements for the EU centralised procedure. Experience in co-ordinating post-approval variations renewals responses to questions PSURs etc. for EU centralised products is desirable., • Experience of regulatory requirements in other countries/regions is desirable., • Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials would be advantageous., • Experience in working with document management systems., • Experience successfully leading departmental and cross-functional teams without authority., • Experience authoring and implementing processes., • Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred. Knowledge & Other Requirements • Excellent verbal and written communication skills and interpersonal skills are required., • Demonstrated ability to be a fast learner., • Demonstrated ability to be flexible and adaptable to change to move between projects easily and provide support/expertise where needed., • Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives including ICH standards and the regulatory requirements for assigned markets., • In-depth knowledge of relevant health authorities including people system processes and requirements as evidenced by past effectiveness and successes in conducting HA interactions., • Able to represent Gilead to regulatory authorities when managing standard or more routine negotiations., • Demonstrates strong analytical thinking skills attention-to-detail strong communication and writing skills project management skills and proficiencies with Microsoft Office suite as evidenced through accomplishments in past roles., • Ability to lead and influence programs projects and/or initiatives., • Strong interpersonal skills and understanding of team dynamics., • Proven ability to work successfully in a team-oriented highly-matrixed environment., • When needed ability to travel. It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. Please apply via the Internal Career Opportunities portal in Workday. Required Experience: Manager Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference. Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together. Job Description This exciting role of Regulatory Affairs Associate II CMC sits in Gileads CMC Regulatory Affairs - Small Molecule Group. Responsibilities and qualifications are as follows: Responsibilities: * Provides support for designated regional regulatory activities for PDM CMC Project and Commercial Teams Regulatory Project and Regulatory Submissions Teams with focus on Small/Synthetic Molecules. * Assists designated CMC RA leads in identifying and ranking risks proposing risk mitigation plans. Shadows leads while they develop and execute robust CMC regulatory strategies. * Under the guidance of more senior staff oversees the preparation of CMC regulatory submissions for investigational and commercial products with solid scientific foundations in compliance with ICH and regional requirements and in alignment with company policies and procedures. * Will become proficient in utilizing computerizing systems as per established business processes both within and outside of the GxP environment. * Will train and learn how to prepare regulatory submissions which require some interactions with other members in the CMC regulatory department for investigational and commercial products in line with ICH requirements regional requirements and scientific and company policies and procedures. * Will perform workflows and procedures regarding document tracking indexing and retrieving and disseminating information to the CMC regulatory department. * Participates in group meetings and provides tactical approaches to addressing issues of low to moderate complexity. * May participate in other Subteams and in non-product related projects; may contribute to local process improvements which have an impact on the working of the CMC Regulatory function or other departments. * Learns how to interpret regulatory guidelines and how to comply with statutory requirements. * Learns how to provide regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises. * Proactively invests in own development to acquire regulatory skills and knowledge with manager support. * Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and regulatory trends. Basic Qualifications: * Ph.D. Masters or pharmacy chemistry or related field with experience working in scientific/technical group within a pharma company Preferred Qualifications: * Experience with small molecule/synthetic pharmaceuticals would be preferred * Collaborative proactive and highly organized approach to work. * Demonstrated track record with strategic planning problem solving and working within a global matrix team environment. * Good understanding of the drug development process. * Excellent verbal and written communication skills and ability to interact well with colleagues and stakeholders * Experience in a GMP environment is preferred * Ability to learn on the job is preferred It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. Please apply via the Internal Career Opportunities portal in Workday. Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines At AstraZeneca we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways combining our peoples outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE) we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as possible. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes. Cambridge UK is one of over 400 sites here at AstraZeneca providing a collaborative and vibrant environment where everyone feels comfortable and able to be themselves is at the core of AstraZenecas priorities. * Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA) health authority interactions label discussions and securing approvals. * Develop and implement the programs regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business markets and patients. * Craft the health authority engagement strategy and interaction plan drive the formulation of the briefing document focused on strategy and scientific content lead the team through meeting rehearsals and moderate the meeting itself. * Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions emerging markets RA CMC Labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST. * Deliver regulatory milestones on your team including an assessment of risks and mitigations emerging data and the probability of success. Lead preparation of the regulatory strategy document and target product labeling. * Own the negotiations with health authorities and initiate and deliver key regulatory documents. * Plan and construct the global dossier and core prescribing information including product maintenance supply and compliance activities. * Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance. * Bachelors degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience. * A solid knowledge of regulatory affairs within at least one therapeutic area in both early and late development. * Previous demonstrated experience of regulatory drug development or equivalent and experience with major HA interactions. * Demonstrated competencies of strategic thinking strategic influencing risk evaluation innovation initiative leadership and excellent oral and written communication skills. * Advanced degree preferred. * Experience in Oncology (small molecules & biologics) is preferred. * Prior experience with phase 3 design including end of phase 2 health authority interactions. * Contribution to a regulatory approval including leading response team and labeling negotiations. * Knowledge and understanding of guiding principles in drug development such as benefit/risk profile dose selection or statistical design. * Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. * Ability to work strategically within a business critical and high-profile development program. * Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements. Competitive salary and benefits package on offer: Recognizing the importance of individualized flexibility our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Date Posted 17-Oct-2025 Closing Date 29-Nov-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form. Required Experience: Director Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1

The Senior Manager Regulatory Affairs CMC will be responsible for the development execution and tracking of CMC regulatory activities for assigned BicycleTx programs or projects. You will be responsible for supporting the development of CMC regulatory strategy and processes for their assigned BicycleTx programs or projects working closely with cross-functional colleagues and the Director Regulatory Affairs CMC. As an integral member of the team that will be tasked with CMC product development the Senior Manager Regulatory Affairs CMC will also serve as a subject matter expert (SME) for assigned activities which may involve multiple partners and collaborators and will ensure adherence to relevant regulatory requirements. Key Responsibilities • Responsible for the development and execution of regulatory strategy and submissions for assigned BicycleTx programs or projects with a focus on regulatory CMC including dossiers to support clinical trial applications, • Responsible for the regulatory assessment of change controls maintenance of regulatory files and tracking databases related to CMC submissions, • Collaborate with internal colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content responses to questions audits and inspections, • Manage the preparation drafting review risk analysis and mitigation planning of CMC submissions (e.g. Module 3 IND IMPD amendments and annual reports) for assigned BicycleTx programs or projects, • Developing and maintaining internal cross-functional relationships to support the development and execution of CMC regulatory submissions for assigned BicycleTx programs or projects, • May act as the Global/Regional CMC Regulatory Lead for assigned development programs, • May support the development of processes SOPs and other controlled documents including for Regulatory Affairs activities, • Partners with Regulatory Affairs and cross-functional colleagues to understand the CMC regulatory landscape e.g. views of HAs regulatory precedents labeling differences and other CMC-specific issues and adapts to changes that may impact BicycleTx programs or projects We are also open to those that can commit to a minimum of 0.8FTE (4 day week) We are only considering candidates who have a mix of CMC and Clinical Regulatory Affairs experience. Qualifications : Key Skills and Competencies • Bachelors degree in a scientific field or post-graduate degree preferred, • Strong demonstrable experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry; particularly relating to peptides and drug-conjugates; any in-depth experience may be limited to one specific region (e.g. US or EU)., • General clinical regulatory experience supporting global clinical trial applications (not limited to CMC) is essential., • Working knowledge of FDA EMA ICH and cGMP CMC regulatory guidance and regulations, • Experience and knowledge in preparation of CMC sections of INDs CTAs NDAs MAAs or regional equivalents is required, • Experience and knowledge in the supportive interactions with health authorities including US FDA EMA and/or EU Member States is desirable, • An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required, • Ability to communicate on topics of basic science is essential; a working knowledge of global drug product development is required, • Ability to proactively identify risks and develop risk mitigation strategies, • Adaptable with the ability to generate creative solutions identify different and novel ways to find solutions and adapt to changing priorities and deadlines., • Highly collaborative strong relationship building skills with internal and external partners with a high level of integrity, • Works proactively using solid communication and influencing skills to effectively execute program goals for assigned BicycleTx programs or projects, • Works effectively in a highly complex and fast-paced environment, • Strong organisational and time management skills, • Position may require some domestic and international travel Additional Information : • State-of-the-art campus environment, • Competitive reward including annual company bonus, • 28 days annual leave in addition to bank holidays, • Employer contribution to pension (employee does not have to contribute), • Life assurance cover 4x basic salary, • Private Medical Insurance including optical and dental cover, • Health Cash Plan, • Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. Remote Work : No Employment Type : Full-time Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Experience: years Vacancy: 1

Web Designer & Web Developer Near Cambridge My client, a fast-growing AI company based near Cambridge, is seeking a talented Web Designer & Web Developer to design, build, and maintain the organisations websites and digital content. This role blends creative design, front-end development, and digital content production-ideal for a recent graduate or early-career designer with a strong visual portfolio and solid technical web skills. You will work closely with the marketing and creative teams to shape the companys digital presence, deliver high-quality visual assets, manage multiple web projects, and ensure all online platforms remain modern, engaging, and technically robust. Key ResponsibilitiesWeb Design & Front-End Development Designing and building website pages, templates, and components using HTML, CSS, and modern web standards Managing and updating company websites via CMS platforms (WordPress, Joomla, or similar) Creating wireframes, mock-ups, and page layouts incorporating fonts, colour schemes, imagery, animations, and interactive elements Ensuring usability, responsiveness, accessibility, and smooth user navigation Editing, debugging, and improving existing pages and site structures Implementing SEO best practices and monitoring site performance through analytics Digital Content & Creative Production Producing digital artwork, graphics, and visual assets using Adobe Creative Cloud (Photoshop, Illustrator, InDesign) Supporting creation of 3D and motion content (experience with Blender is an advantage) Creating and editing video and podcast content for marketing and communications Retouching images, developing visualisations, and delivering brand-consistent assets Ensuring branding guidelines are consistently maintained across all digital outputs Website Operations & Management Registering domains and coordinating hosting and DNS updates with internal IT Managing website testing, quality checks, and daily performance evaluations Ensuring compliance with accessibility, privacy, and other digital regulatory requirements Tracking traffic and user engagement through analytics tools and producing insights Keeping up to date with modern web design trends, technologies, and best practices Cross-Team Collaboration Working with internal teams to plan social media assets, video content, and marketing campaigns Liaising with external agencies, photographers, creative partners, and printers Supporting the 3D designer and other creative roles as needed RequirementsEssential Proficiency in HTML, CSS, and at least one major CMS (WordPress, Joomla, etc.) Strong graphic design skills, particularly within Adobe Creative Cloud (Photoshop, Illustrator, InDesign) Ability to produce high-quality digital artwork and retouched imagery Excellent time management and organisational skills, with the ability to manage multiple projects Strong communication skills and the ability to work independently within a small team Full UK driving licence Full eligibility to work in the UK (no sponsorship available) Desirable Experience with Blender or other 3D creation tools Video editing or podcast production experience Knowledge of desktop publishing (DTP) software Familiarity with accessibility standards and GDPR/privacy requirements Understanding of SEO, analytics tools, and performance optimisation Basic understanding of JavaScript or front-end frameworks Role Details Location: near Cambridge Working Pattern: Office-based, 5 days per week Team: Creative, technically varied role within a small and expanding marketing team Opportunity: Shape the companys entire digital presence in a high-growth tech environment Interested? Please Click Apply Now!Web Designer & Web Developer Near Cambridge TPBN1_UKTJ

The Director will execute strategies aligned with Adobe’s Global Partner Program and ensure effective communications within the team.

Nights - 8pm - 8am (including every other weekend).Are you a naturally caring person and want to help make a difference in people’s lives? .If you are kind, compassionate and committed, we would love for you to join our care team at our lovely nursing home, Mill Lane.Mill Lane spec

Changing the world through digital experiences is what Adobe’s all about. Leading a team of Partner Sales Managers to manage named Global & Regional partners for developing and driving execution of revenue‑driving programmes and initiatives, enable and certify Partners to ensure they are deliver

Submit your CV and any additional required information after you have read this description by clicking on the application button.As a Maintenance Assistant at a Barchester care home, you'll help to create the safe and attractive surroundings that enable us to give our residents the quality care and

Changing the world through digital experiences is what Adobe’s all about. Leading a team of Partner Sales Managers to manage named Global & Regional partners for developing and driving execution of revenue‑driving programmes and initiatives, enable and certify Partners to ensure they are deliver

Considering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out.As a Bank Care Assistant at a Barchester care home, you'll help residents enjoy each day by making sure they get the quality care and support they deserve.You'll assist with

The Director will execute strategies aligned with Adobe’s Global Partner Program and ensure effective communications within the team.

All potential candidates should read through the following details of this job with care before making an application.As a Bank Care Assistant at a Barchester care home, you'll help residents enjoy each day by making sure they get the quality care and support they deserve.You'll assist with daily li

A leading technology company in the UK is seeking a Digital Strategy Principal Consultant to lead impactful consulting engagements for major brands, primarily in Telecoms and Media.You will collaborate with sales teams and deliver strategic recommendations for customer experience transformation.The

Apply below after reading through all the details and supporting information regarding this job opportunity.As a Bank Senior Care Assistant at a Barchester care home, you'll look after the different needs of our residents to enable us to deliver quality, person-centred care and support.Your role wil

Adobe’s Digital Strategy Group works with C‑level leadership at leading companies to advise on digital strategy and transformation for customer‑centric experiences, audience monetisation and digital innovation with AI & Agentic. Develop & deliver thought leadership to customer & Adobe ecosyste

Is this your next job Read the full description below to find out, and do not hesitate to make an application.As a Bank Housekeeping Assistant at a Barchester care home, you'll help to create a warm and homely environment that enables us to meet each resident's unique needs.Keeping the home clean an

Hours: 8am -8pm on a rolling rota of 3 shift on 3 shifts off.Choose to live life in Colour by working at Borough Care where we believe that everyone should be encouraged and supported to live their best possible life.By working with us you will receive some excellent rewards & benefits including:.An

All candidates should make sure to read the following job description and information carefully before applying.As an Activities Assistant at a Barchester care home, you'll deliver imaginative, fun and varied activities to ensure our residents can enjoy an environment that is motivational and fulfil

We're looking for caring and reliable Community Carers to join our clients team, providing essential support to elderly and vulnerable individuals in their own homes.If you're looking for a rewarding role with excellent benefits and a supportive team, we want to hear from you!.Twice-yearly performan

We are not able to sponsor applicants for this role.Here at Wellburn, our lovely family run business operates a little differently to a lot of other businesses.Everyone is different, and we love that.Our recruitment policy is as much to do with personality as it is about qualifications.We need you t

Female Care Assistant - Driver with Own Vehicle Location: Wirral Pay Rate: 14.IMPORTANT: Unfortunately, Routes are unable to offer a job to anyone who does not have the right to work in the UK or needs employer support.Female Requirement: This role is advertised for female care assistants only a

We are not able to sponsor applicants for this roleA little bit about usHere at Wellburn, our lovely family run business operates a little differently to a lot of other businesses.Everyone is different, and we love that.Our recruitment policy

Senior Health Care AssistantWhen registering to this job board you will be redirected to the online application form.Please ensure that this is completed in full in order that your application can be reviewed.Position: Senior Health Care AssistantCare home:St Andrews Court<br&

Why join us? Were proud of our happy home and are dedicated to creating a place where everyone enjoys coming to work each day.As well being part of a lively and supportive team, we are surrounded by fascinating residents who also bring so much to our lives every day too.Benefits of joining our team

Female Complex Care Assistant Location: Birkenhead Pay Rate: £13.IMPORTANT: Unfortunately, Routes are unable to offer a job to anyone who does not have the right to work in the UK or needs employer support.FEMALE REQUIREMENT: This role is advertised for female care assistants only as a Genuine O

We are not able to sponsor applicants for this roleA little bit about usHere at Wellburn, our lovely family run business operates a little differently to a lot of other businesses.Everyone is different, and we love that.Our recruitment policy

Care Assistant The Manor House, North Walsham 48 hours per week 7am - 7pm including every other weekend £12.Are you a naturally caring person and want to help make a difference in people’s lives? If you are kind, compassionate and committed, we would love for you to join our care team at our love

ABOUT THE ROLE As a Bank Care Assistant at a Barchester care home, you'll help residents enjoy each day by making sure they get the quality care and support they deserve.You'll assist with daily living, providing support and companionship and sharing great moments and memories too.It's a chance to

Care Assistant - Night shifts Mill Lane, Felixstowe £12.Nights - 8pm - 8am (including every other weekend) Are you a naturally caring person and want to help make a difference in people’s lives? If you are kind, compassionate and committed, we would love for you to join our care team at our lovel

ABOUT THE ROLE As a Senior Care Assistant at a Barchester care home, you'll look after the different needs of our residents to enable us to deliver quality, person-centred care and support.Your role will involve supervising and inspiring a team of dedicated Care Assistants alongside the Deputy Gener

Care Assistant The Manor House, North Walsham 48 hours per week 7am - 7pm including every other weekend £12.Are you a naturally caring person and want to help make a difference in people’s lives? If you are kind, compassionate and committed, we would love for you to join our care team at our love

ABOUT THE ROLE As a Care Assistant at a Barchester care home, you'll help residents enjoy each day by making sure they get the quality care and support they deserve.You'll assist with daily living, providing support and companionship and sharing great moments and memories too.It's a chance to bring

At Colten Care we are proud to offer career development opportunities, and a range of pay enhancements across our roles.Were looking for a reliable and committed Kitchen Porter to join our team and become a valued part of day-to-da.

ABOUT THE ROLE As a Care Assistant at a Barchester care home, you'll help residents enjoy each day by making sure they get the quality care and support they deserve.You'll assist with daily living, providing support and companionship and sharing great moments and memories too.It's a chance to bring

Paediatric Complex Care Healthcare Assistant ColchesterAre you looking for the next step in your healthcare career? Do you want a role with a consistent rota and the opportunity to make a real difference in a childs life? First Option Healthcare is re

ABOUT THE ROLE As a Bank Care Assistant at a Barchester care home, you'll help residents enjoy each day by making sure they get the quality care and support they deserve.You'll assist with daily living, providing support and companionship and sharing great moments and memories too.It's a chance to

Complex Care Assistant Location: Yarm Pay Rate: £13.IMPORTANT: Unfortunately, Routes are unable to offer a job to anyone who does not have the right to work in the UK or needs employer support.About Us&l

ABOUT THE ROLE As a Bank Care Assistant at a Barchester care home, you'll help residents enjoy each day by making sure they get the quality care and support they deserve.You'll assist with daily living, providing support and companionship and sharing great moments and memories too.It's a chance to

We are recruiting on behalf of our client, a young professional in their 20swho is looking for a like-minded individual to join their care team.Youll be part of a close-knit team of Personal Assistants providing one-to-one personal care and support for independent living.Start:ASAP

ABOUT THE ROLE As a Care Assistant at a Barchester care home, you'll help residents enjoy each day by making sure they get the quality care and support they deserve.You'll assist with daily living, providing support and companionship and sharing great moments and memories too.It's a chance to bring

Why join us?Were proud of our happy home and are dedicated to creating a place where everyone enjoys coming to work each day.As well being part of a lively and supportive team, we are surrounded by fascinating residents who also bring so much to our lives every day too.Benefits of

ABOUT THE ROLE As a Kitchen Assistant at a Barchester care home, you'll help to provide the first-class food and hospitality that enable us to give our residents exceptional all-round care and support.A healthy, nutritious diet is vital to ensuring our residents' wellbeing and helping them enjoy dai

Casual Senior Night Care Assistant at Reinbek£15.Choose to live life in Colour by working at Borough Care where we believe that everyone should be encouraged and supported to live their best possible life.By working with us you will receive some excellent rewar

ABOUT THE ROLE As a Housekeeping Assistant at a Barchester care home, you'll help to create a warm and homely environment that enables us to meet each resident's unique needs.Keeping the home clean and safe is no small task, which is why the role of Housekeeping Assistant is so important.The variety