Senior Director or VP of Regulatory Affairs

Role: Senior Director or VP of Regulatory Affairs responsible for leading regulatory strategy, submissions, and agency interactions for oncology therapeutics. Objectives include ensuring regulatory compliance, supporting product development, and facilitating successful BLA approvals. Responsibilities encompass developing global regulatory strategies, overseeing IND/BLA filings, managing relationships with health authorities (FDA, EMA), and aligning regulatory plans with clinical, CMC, quality, and commercial functions. The role involves building and leading the regulatory function, mentoring teams, and providing strategic guidance to executive leadership. Qualifications: Advanced life sciences degree (12+ years industry experience) or Bachelor's with 15+ years; 5+ years of senior regulatory leadership, with proven success in BLA submissions for oncology drugs; deep knowledge of US and global regulatory landscapes; experience managing external vendors and cross-functional teams. High-Value: Oncology, BLA submissions, US and ex-US regulatory strategy, leadership engagement with FDA/EMA, clinical development to commercialization, and experience in biologics or small molecules. Work setup: Onsite in Brighton, MA, 4 days/week.