Sr Manager, Regulatory Affairs CMC

Role: Lead CMC regulatory strategy and program leadership for cell therapy and viral vector products, including T-cell drug and LVV manufacturing. Objectives: ensure regulatory alignment across early to late-stage development, registration, and post-approval activities, facilitating global submissions and inspections. Responsibilities: guide regulatory aspects of autologous T-cell manufacturing, LVV production, and lifecycle management; define phase-appropriate CMC content; support process changes and comparability strategies; author and review regulatory documents for INDs, BLAs, and supplements; lead responses to health authority inquiries. Qualifications: Bachelor's degree with 8+ years or advanced degrees with relevant experience in biotech/pharma, regulatory affairs, or related fields; strong background in cell and gene therapy, GMP, ICH, and regional requirements; hands-on experience with autologous T-cell and LVV manufacturing processes; proven ability to develop and execute global regulatory strategies. High-Value: expertise in CAR T-cell therapies, viral vectors, process validation, analytical method development, and lifecycle management of advanced therapies; experience supporting early clinical, pivotal, and commercial programs; familiarity with international regulatory submissions and multi-site manufacturing. WorkSetup: hybrid model based in Santa Monica, CA, with planned relocation to CA offices by 2027; supports flexible work policies.