Director / Associate Director Regulatory CMC in England

The (Associate) Director, Post-Market Regulatory CMC will lead lifecycle CMC regulatory strategy and execution for commercial Advanced Therapy Medicinal Products (ATMPs), biologics, and oncology products. This role supports global regulatory compliance, manages post-approval changes, and drives high-quality submissions to ensure product availability for patients.

Key Responsibilities

• Regulatory Strategy & Lifecycle Management: Lead global post-market CMC regulatory strategy for assigned ATMP and biologics products within the oncology portfolio. Monitor evolving regulatory requirements related to ATMPs, viral vectors, cell-based products, gene-modified cells, mAbs, and other biologics across major agencies (FDA, EMA, MHRA, PMDA, Health Canada). Provide strategic regulatory input to change control assessments, comparability studies, process validation updates, and long-term lifecycle planning. Ensure regulatory strategy supports commercial supply continuity, product robustness, and ongoing GMP compliance.
• CMC Documentation & Submissions: Oversee preparation, review, and submission of post-approval CMC supplements, variations, amendments, periodic reports, renewals, and agency commitments for ATMPs and biologics. Ensure content is scientifically sound and aligned with global expectations, including ICH Q5–Q12, ATMP-specific guidelines, and regional oncology requirements. Drive high-quality CMC content for complex areas such as potency assays, raw material control, vector characterization, cell-handling processes, chain-of-identity/chain-of-custody, scalability, cold-chain modifications, and advanced analytics.
• Cross-Functional & Technical Partnership: Serve as the primary CMC Regulatory lead on cross-functional product teams for ATMP/biologics in oncology. Partner closely with Manufacturing and Quality to evaluate process improvements, technology transfers, supplier changes, and analytical method lifecycle activities. Provide regulatory input on deviations, CAPAs, and comparability protocols involving living cells, viral vectors, or biologic drug substance/drug product.
• Health Authority Interactions: Manage and prepare responses to global Health Authority queries related to ATMP/biologics CMC issues. Contribute to briefing packages and support participation in regulatory meetings (e.g., FDA Type II/III meetings, EMA post-authorization procedures, innovation office consultations). Interpret and disseminate new guidance relevant to ATMPs, cell therapy manufacturing, gene therapy platforms, and biologics used in oncology.

Qualifications

• Education: Bachelor’s, Master’s, or PhD in Cell Biology, Molecular Biology, Biochemistry, Bioengineering, Pharmaceutical Sciences, or related field.
• Experience: 8+ years (or 6+ with advanced degree) in Regulatory CMC, Technical Development, Quality, or Manufacturing sciences, with significant experience in ATMPs, cell therapy, gene therapy, viral vectors, or biologics. Demonstrated experience with post-approval CMC for complex modalities. Strong understanding of regulatory requirements for oncology products and ATMP-specific regulations (e.g., EU ATMP framework, FDA guidance for gene therapy/cell therapy products).
• Skills: Expertise in CMC concepts unique to ATMP and biologics: potency, heterogeneity, cell expansion, transduction efficiency, vector stability, cryopreservation, sterility validation, etc. Excellent leadership, communication, and project management skills. Ability to interpret complex scientific data and articulate clear regulatory strategy. Strong writing, analytical, and organizational capabilities.

Seniority Level: Director

Employment Type: Full-time

Job Function: Science and Manufacturing

Industries: Biotechnology Research and Pharmaceutical Manufacturing