Director / Associate Director Regulatory CMC
18 hours ago
Manchester
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., • 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., • 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., • 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 • 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., • 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.