Sr Manager, Regulatory Affairs CMC
Core
Drive complex CMC regulatory activities for Kite's cell therapy/CAR-T portfolio across clinical and commercial development, supporting global regulatory strategies and submissions.
Role type
Senior Manager, Regulatory Affairs CMC
Builds
Global regulatory strategies and CMC submissions for cell therapy products
Domain
Biotechnology / Cell Therapy / CAR-T
Required skills
CMC regulatory requirements for ATMPs, ICH requirements, global regulatory frameworks, risk assessment, cross-functional collaboration, lifecycle management, manufacturing change controls, inspection readiness, health authority response management
Preferred skills
CAR-T manufacturing comparability, vector-related changes, manufacturing site expansion strategies
Technologies
Regulatory submission systems, CMC repositories
Responsibilities
Prepare and review complex CMC regulatory submissions (INDs, CTAs, BLAs, MAAs), develop global CMC regulatory strategies, ensure harmonization of Module 3 content, identify CMC risks and mitigation strategies, support manufacturing site expansion and qualification, lead inspection readiness activities, provide input on manufacturing change controls, present project status and risks to cross-functional teams, contribute to continuous improvement of CMC capabilities
Seniority
Senior Manager, hands-on IC with leadership responsibilities