Director / Associate Director Regulatory CMC

2 weeks ago

London, Greater London, United Kingdom Discover International Full time £900,000 - £1,200,000 per year

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.

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