- Recommend direction for essential operations and new programs in collaboration with local and global team members.
- Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with the established requirement.
- Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success. 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.
- 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 all 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.
- To be responsible for reviewing and ensuring the quality of detailed scientific and technical CMC information are presented clearly and supporting conclusions are adequately evidenced by the data.
- Strong scientific background with track record of developing global regulatory CMC strategies.
- 5+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
- Experience with pharmaceutical development of biologics, including mammalian drug substances processes, analytical characterization, process scale-up, and regulatory registration of products is required.
- Experience liaising with Global Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions and product development meetings, international experience preferred, 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.
- Practical experience to provide oversight to ensure CMC regulatory submissions are compliant
- Writing and submission of the CMC information for all or a portion of at least 1 NME BLA/NDA/MAA is highly desirable.
- Bachelor's degree in a relevant field of science; relevant Master's or PhD preferred
- Project management certification desirable #J-18808-Ljbffr
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Senior Associate - Abingdon, Oxfordshire, United Kingdom - Immunocore
Description
Associate Director, Regulatory Affairs CMCVacancy Name Associate Director, Regulatory Affairs CMC
Employment Type Permanent
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.
We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients.
You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies.We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity.
We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback.
We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.
Key Responsibilities As the Associate Director, Regulatory Affairs CMC you will be responsible and accountable for Regulatory CMC development, registration, and post-approval strategies.
You will ensure global strategies are accomplished across both new product development and existing portfolio life cycle management and manage preparation of dossiers in eCTD format.
As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, Supply Chain and Commercial project teams throughout clinical development and commercial lifecycle.
Key responsibilities will include authoring CMC modules/updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorisation applications.
Development of CMC filing strategies for proposals to project teams and senior leadership.Independently manage the planning, authoring, preparation 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, IND submissions and amendments, marketing applications, supplements, variations and other communications with regulatory authorities (e.g., Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/EUP/USP/BP Global regulations and guidance to ensure CMC compliance.
