Sr Manager, Regulatory Affairs CMC

Role: Regulatory CMC Lead for cell therapy and viral vector programs, overseeing global regulatory strategies across development stages. Responsibilities: develop and execute regulatory submission plans for T-cell and lentiviral vector manufacturing, guide process development, lifecycle management, and change controls, and ensure readiness for pivotal trials and commercialization. Lead or support health authority interactions, author technical documentation, and manage cross-functional teams. Qualifications: Bachelor's degree with 8+ years or advanced degrees with relevant biotech/pharma/regulatory experience, including hands-on knowledge of autologous T-cell and LVV manufacturing, GMP, and global regulatory requirements. Preferred: PhD or PharmD, extensive experience in cell and gene therapy, process validation, analytical methods, and regulatory submissions. High-Value: focus on autologous T-cell therapy and LVV manufacturing, early to late-stage clinical development, global regulatory engagement, and lifecycle management. Work setup: hybrid model based in Santa Monica, with planned relocation to California offices in 2027; supports flexible work policies.