Associate Director, Regulatory Affairs CMC

1 month ago

Abingdon Oxfordshire, United Kingdom Immunocore Full time
Job Details: Associate Director, Regulatory Affairs CMC

Full details of the job.

Vacancy Name

Vacancy Name Associate Director, Regulatory Affairs CMC

Vacancy No

Vacancy No VN194

Employment Type

Employment Type Permanent

Location of role

Location of role Abingdon

About the Company

About the Company 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.

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

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 communicate and negotiate with international Health Authorities, directly and indirectly. 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.

KEY RESPONSIBILITIES
• 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., briefing documents for meetings)
• 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.
• 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.
• Manage preparation and internal review of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance's 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 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.
• Assisted in preparing for manufacturing inspection readiness and provide expert input during inspections, when required.

EXPERIENCE & KNOWELEDGE
Essential
• 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 in managing, authoring, and submitting IMPDs or IND Module 3 and Module 3 / 2.3 sections for Marketing Authorisations. Contribution to the CMC information in at least 1 marketing authorisation application submission 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.
• Demonstrated ability to work well within a matrix structure in a complex environment.
• Practical experience to provide oversight to ensure CMC regulatory submissions are compliant
• Excellent written and oral communication skills are required.
• Active participation in Agency/Industry groups/forums is preferred.
• Experienced working effectively to meet deadlines, and can adjust to changing priorities
• Strong communication skills, professional presence, and ability to engage effectively with stakeholders at all levels
• Collaborative and able to motivate and energise cross functional team members to achieve aggressive goals
• Strong problem-solving, and analytical skills, able to facilitate discussions among groups with diverse technical expertise, and progress decisions on complex issues

Preferred Experience & knowledge
• Experience in managing, preparing, submitting Module 3/ IMPDs, and Module 3 for BLAs/NDAs, and MAAs. Writing and submission of the CMC information for all or a portion of at least 1 NME BLA/NDA/MAA is highly desirable.
• Experience in preparing and conducting Health Authority Meetings in EU. Ability to develop and maintain an ongoing liaison relationship with global Health Authorities.

EDUCATION & QUALIFICATIONS
• Bachelor’s degree in a relevant field of science; relevant Master's or PhD preferred
• M.S., PharmD, or Ph.D., with 5+ years’ experience or BS with 8 years’ experience.
• Project management certification desirable #J-18808-Ljbffr

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