Director / Associate Director Regulatory CMC

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.

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).

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.