Manager, Regulatory Affairs CMC

Role: Regulatory Affairs CMC Manager supporting cell and gene therapy, including lentiviral vector (LVV) manufacturing, testing, and lifecycle management. Responsibilities: prepare and submit global regulatory filings (INDs, CTAs, BLAs, MAAs), contribute to Module 3 (CMC) content, support regulatory strategies, partner with cross-functional teams on process development, manufacturing, and analytical testing, and ensure inspection readiness. Maintain regulatory documentation, assess change controls, and support lifecycle activities related to LVV and cell therapy products. Requirements: Bachelor's degree with 6+ years (or Master's with 4+ years) in a scientific discipline; strong knowledge of CMC regulatory requirements, ICH guidelines, and viral vector manufacturing; experience with regulatory submissions, health authority interactions, and lifecycle management. Preferred: experience in cell/gene therapy, CAR-T, ATMP, and familiarity with viral vector safety and characterization, manufacturing, and supply chain. HighValue: focus on viral vector and cell therapy modalities, regulatory filings for advanced therapies, lifecycle management, and cross-functional collaboration with manufacturing and quality teams. WorkSetup: office-based/hybrid roles in CA or NJ, with planned relocation from Santa Monica to other locations beginning 2027; flexible remote options.