VP, Regulatory Affairs
Core
Develop and own global regulatory strategies for gene editing, cell therapy, and advanced medicinal therapy programs from early development through BLA/MAA submission.
Role type
VP, Regulatory Affairs (Strategy & Leadership)
Builds
Global regulatory strategies and submission packages for gene editing and cell therapy programs
Domain
Biotechnology / Gene Editing / Cell Therapy
Required skills
Global regulatory strategy, FDA/EMA engagement, IND/CTA/BLA/MAA submissions, regulatory risk assessment, team leadership, cross-functional collaboration, regulatory intelligence, contract management
Preferred skills
Gene therapy/gene editing experience, CBER-regulated programs, rare/orphan disease frameworks, expedited designation pathways (RMAT/Breakthrough/Orphan), lean environment operation
Technologies
None stated
Responsibilities
Develop global regulatory strategies for all programs; serve as primary interface with FDA/EMA; lead regulatory meetings and negotiations; oversee IND/CTA/BLA/MAA filings; manage regulatory teams and CROs; monitor evolving regulatory requirements
Seniority
VP, Strategy & Leadership