Senior International Regulatory Affairs Director
Core
Lead international regulatory strategy for complex cell therapy programs, shaping evidence generation, submission strategy, and labeling to accelerate global patient access.
Role type
Senior International Regulatory Director (Cell Therapy)
Builds
Global regulatory submissions, approvals, and product labels for cell and gene therapies
Domain
Biopharmaceuticals / Cell and Gene Therapy (CGT)
Required skills
International regulatory strategy, cell therapy development, global regulatory systems, Health Authority engagement, dossier planning, labeling negotiation, cross-functional leadership, program management, commercial acumen, change leadership
Preferred skills
FDA/EMA advisory committee experience, policy forum membership, business development due diligence, people coaching
Technologies
BLA, MAA, IND, IMPD, CMC components
Responsibilities
Own international strategy for complex cell therapy programs; lead end-to-end strategy from development through launch; integrate clinical, CMC, and commercial considerations; orchestrate Health Authority engagements; direct dossier planning and labeling; ensure international market readiness; assess evidence and risk; lead the international regulatory team; champion innovative regulatory strategies
Seniority
Senior, hands-on IC with leadership responsibilities