Senior Director, Regulatory Affairs

Role: Senior global Regulatory Affairs leader overseeing early and late-stage development programs, with a focus on immuno-oncology or biologics modalities. Responsibilities include developing and driving regulatory strategies, managing filings and health authority interactions (notably FDA and EMA), and guiding clinical development plans for CytomX's clinical pipeline, including PROBODY therapeutics like CX-2051 and CX-801. The position involves representing the company in regulatory meetings, ensuring submission readiness, and aligning regulatory positions across regions. Collaboration spans clinical, CMC, and commercial teams, with a focus on risk management and regulatory compliance. Requirements: Bachelor's degree in a life sciences field; 10+ years in biotech/pharma regulatory roles, with substantial experience in global late-stage development, regulatory submissions, and agency interactions. Advanced degrees (PharmD, Ph.D., MD) preferred. High-value specifics include expertise in biologics and oncology, experience with expedited pathways, and familiarity with US/EU regulatory landscapes. The role reports to the SVP of Regulatory Affairs, is hybrid based in Emeryville, CA, with 20% travel expected.