Senior International Regulatory Affairs Director
Core
Lead international regulatory strategy for complex cell therapy programs, shaping evidence generation, submission plans, and labeling to accelerate global market access.
Role type
Senior International Regulatory Director (Cell Therapy)
Builds
Global regulatory submissions, dossiers, and approved labels for cell and gene therapy products
Domain
Biopharmaceuticals / Cell and Gene Therapy (CGT)
Required skills
International regulatory strategy, cell therapy development, global submission management, health authority engagement, cross-functional leadership, dossier construction, labeling negotiation, risk assessment, program management, commercial acumen
Preferred skills
FDA advisory committee experience, EMA oral hearing preparation, policy forum membership, business development due diligence, marketed product compliance
Technologies
BLA, MAA, IND, IMPD, CMC regulations
Responsibilities
Own international strategy for complex cell therapy programs; lead end-to-end regulatory plans from development through launch; orchestrate health authority engagements and advisory preparations; direct dossier planning and labeling negotiations; lead the international regulatory team; assess evidence and probability of success; champion innovative regulatory strategies
Seniority
Senior, hands-on IC with team leadership