Sr Manager, Regulatory Affairs

Role: Senior Regulatory Affairs professional leading global regulatory strategies for biopharmaceutical cancer therapies, including cell and gene therapies. Responsibilities: develop and execute regulatory plans, manage submissions (IND, CTA, BLA, MAA) to authorities like FDA and EMA, serve as the US Regulatory Lead in cross-functional teams, provide regulatory guidance, monitor compliance, prepare for and liaise with health authorities, and mentor team members. Requirements: BA/BS with 8+ years' experience or MA/MS/MBA with 6+ years, with a strong track record in regulatory submissions and managing regulatory projects; experience in late-stage investigational or marketed products preferred. High-Value: focus on innovative cancer immunotherapies such as CAR T-cell therapies, working across multiple phases of development (clinical trial phases, regulatory submissions), with emphasis on compliance with global regulations, GxP, and working on cross-functional teams. Location: flexible, with a hybrid onsite/remote working setup in Santa Monica, Foster City, or Parsippany, and planned relocation to El Segundo/Thousand Oaks in 2027.