Senior Director, Regulatory Affairs

Role: Senior Director of Regulatory Affairs overseeing global regulatory strategies for Summit's oncology programs, including multiple Phase 3 clinical trials in NSCLC and colorectal cancer. Responsibilities: lead IND/CTA submissions, guide global marketing applications (BLA/MAA), develop development landscape assessments, advise on regulations, potentially lead labeling teams, and support cross-functional collaboration with development and partner teams. Qualifications: Bachelor's in life sciences; 10+ years in pharma regulatory affairs with experience in US, EU, and other major regions; proven strategic leadership, project management, and regulatory submission success, including BLA/NDA/MAA processes; strong communication and negotiation skills; experience with oncology therapeutics and global clinical development. HighValue: oncology (NSCLC, CRC), late-stage (Phase 3), IND/CTA and BLA/MAA submissions, cross-region regulatory leadership, collaboration with development teams, and experience in major markets (US, EU, China). WorkSetup: not specified; travel up to 5%.