Manager, Regulatory Affairs CMC

Role: Regulatory Affairs CMC Manager supporting cell and gene therapy programs, with focus on lentiviral vector manufacturing and lifecycle management. Responsibilities: prepare and submit global regulatory filings (INDs, CTAs, BLAs, MAAs); contribute to Module 3 (CMC) content ensuring compliance with global regulations; support regulatory strategies and health authority interactions; assess manufacturing changes and their regulatory impact; contribute to inspection readiness and lifecycle activities; maintain accurate documentation and identify regulatory risks. Requirements: Bachelor's degree plus 6 years or Master's degree plus 4 years in a scientific discipline; strong knowledge of CMC regulatory requirements, ICH guidelines, and cell/gene therapy regulation; experience with lentiviral vectors, viral vector manufacturing, characterization, and lifecycle management; prior experience supporting regulatory submissions and interactions. High-Value: focus on cell and gene therapy, viral vectors, late-stage clinical or commercial programs, regulatory strategy development, manufacturing changes, and lifecycle management. Work setup: hybrid, office-based in CA or NJ; relocation planned for 2027; flexible work policy with remote options.