Sr Manager, Regulatory Affairs CMC
Core
Lead global CMC regulatory strategies for personalized CAR T-cell therapies and lentiviral vectors (LVV) from early-stage development through commercial lifecycle.
Role type
Senior Manager, Regulatory Affairs CMC
Builds
Personalized cell therapy drug products and lentiviral vectors for cancer treatment
Domain
Biopharmaceuticals / Cell Therapy / Gene Therapy
Required skills
Global CMC regulatory strategy, T-cell manufacturing oversight, Lentiviral vector manufacturing expertise, IND/BLA/MAA submission execution, Process validation and comparability, Health authority engagement, Risk assessment, Change control management
Preferred skills
PhD in scientific discipline, 8+ years of relevant experience in cell therapy or gene therapy
Technologies
Bioreactors, Automated manufacturing systems, Analytical testing platforms
Responsibilities
Define phase-appropriate CMC content and evidence expectations for T-cell and LVV products; Lead integrated global CMC regulatory strategies across development stages; Author and review CMC sections for regulatory submissions; Guide development of control strategies and validation plans; Support site additions, tech transfers, and manufacturing network expansion; Present status, risks, and recommendations to technical teams and leadership.
Seniority
Senior, hands-on IC with leadership responsibilities