Senior Manager, Regulatory Affairs CMC - Oxford
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry\\\'s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients\\\' lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
As the Senior Manager, Regulatory Affairs CMC you will be responsible for managing multiple Regulatory CMC activities across the product portfolio. This will include communication with international Health Authorities, directly and indirectly. As part of the Regulatory CMC team, you will ensure compliance with current global regulatory CMC requirements, develop and implement regulatory CMC strategies and manage the preparation and maintenance of regulatory CMC dossiers in eCTD format. The role will work with Regulatory, Pharmaceutical Development, Clinical, Supply Chain and Commercial project teams throughout clinical development and commercial lifecycle.
Key responsibilities will include the authoring, development, filing and archiving activities for CMC modules/updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of global clinical trial and marketing authorisation applications.
Key Responsibilities:
* Contribute to the planning, preparation/authoring and internal review of CMC documentation for regulatory CMC submissions for assigned biological programmes in several phases of clinical development, global marketing applications, and post-approval life cycle activities, Clinical Trial Authorisation applications, new IND submissions and amendments, marketing applications, supplements, variations, responses to Requests for Information and other communications with regulatory authorities (e.g., briefing documents for meetings)
* Compliance with applicable EMA/FDA/ICH/WHO/Global regulations
* Manage preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards
* Represent Immunocore in Health Authority CMC meetings and lead preparation activities for meetings with Health Authorities on CMC-related matters.
* Interact directly with international Health Authorities. Participate in and facilitate agency CMC meetings.
* Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success. Provide solutions to prevent the recurrence of issues.
* Stay up-to-date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share experience with others to support their development.
* Maintain constructive relations with essential colleagues, e.g. colleagues within Immunocore, Alliance Partners, and Health Authority representatives.
* Evaluate new business development opportunities or participate in due diligence teams.
* Evaluate change proposals for global regulatory impact and plan global variations and amendments.
* Planning and preparation of IND/CTA/IMPD, BLA / MAA and NDS CMC submissions working with senior CMC leadership for all projects within Immunocore, including the coordination, preparation and review of publishing-ready Module 3, Module 2, Module 1 eCTD sections associated with CMC.
* Ensure that the quality of detailed scientific and technical CMC information are presented clearly and supporting conclusions are adequately evidenced by the data.
* Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Education, Experience and Knowledge:
Essential
* 5+ years\\\' experience in a biopharmaceutical organization, including a minimum of 3 years\\\' experience in a RA CMC product lead role, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
* Undergraduate degree in scientific discipline, with advanced degree: MS, PharmD, PhD, M.D. desirable, but not required.
* Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
* Experience with providing strategic regulatory guidance to drug development, registration, and post-market support teams.
* Demonstrated ability to work well within a matrix structure in a complex environment.
* Collaborative and able to motivate and energise cross functional team members to achieve aggressive goals.
* Must be flexible and comfortable with ambiguity in a fast-paced, lean company environment.
Preferred Experience & Knowledge
* Experience in managing, preparing, submitting Module 3/ IMPDs for clinical trial applications, and Module 3 sections for BLAs/NDAs, and MAAs. Writing and submission of the CMC information for at least 1 NME BLA/NDA/MAA is highly desirable.
* Experience in preparing, and/or conducting Health Authority Meetings. Ability to develop and maintain an ongoing liaison relationship with global Health Authorities.
