Regulatory CMC Director (Cell & Gene Therapy)
Core
Lead global CMC regulatory strategy for cell and gene therapy programs, ensuring efficient approvals and risk-mitigated plans across development stages.
Role type
Director, Regulatory CMC (Cell & Gene Therapy)
Builds
IND, IMPD, BLA, Master Files, and annual reports for cell and gene therapy products.
Domain
Biopharmaceuticals / Cell & Gene Therapy / Regulatory Affairs
Required skills
Global CMC regulations, Health authority engagement, IND/IMPD/BLA/MAA filings, Cross-functional team leadership, Risk management, Lifecycle management, Strategic planning, Standards development, People leadership
Preferred skills
CGT-specific comparability strategies, Potency assays, Control strategy development, eCTD publishing tools, Expedited pathways experience, Matrixed environment experience, Analytics/automation for regulatory processes
Technologies
eCTD, Document management systems
Responsibilities
Develop global CMC regulatory strategies, Interpret global regulations to identify risks, Lead dossier preparation and health authority interactions, Manage regulatory dossiers throughout product lifecycle, Develop regulatory templates and best practices, Lead and develop high-functioning teams
Seniority
Director, strategic leadership & team management