Sr Manager, Regulatory Affairs CMC
Core
Senior Manager driving CMC regulatory strategies and submissions for Kite's global cell therapy/CAR-T portfolio across clinical and commercial development.
Role type
Senior Manager, Regulatory Affairs CMC
Builds
Global regulatory strategies and compliant CMC submissions for CAR-T products
Domain
Biotechnology / Cell Therapy / CAR-T
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory requirements for ATMPs, ICH requirements, CMC submission authoring, lifecycle management, risk assessment, cross-functional collaboration, strategic planning, inspection readiness support, manufacturing change control assessment, health authority response preparation
Preferred skills
CAR-T manufacturing comparability knowledge, vector-related change expertise, manufacturing site expansion experience, global harmonization of Module 3 content
Technologies
Regulatory submission systems, CMC repositories
Responsibilities
Develop and execute global CMC regulatory strategies; prepare and review complex CMC submissions (INDs, CTAs, BLAs, MAAs); support lifecycle management and vector-related changes; ensure global harmonization of Module 3 content; identify CMC risks and recommend mitigation strategies; support manufacturing site expansion and qualification; lead inspection readiness activities; prepare health authority responses; assess manufacturing change controls; maintain CMC registered details; present project status and risks; drive continuous improvement initiatives; coach less experienced colleagues
Seniority
Senior Manager, hands-on IC with strategic input and team guidance