Senior Director or VP of Regulatory Affairs

Role: Senior Director or VP of Regulatory Affairs leading regulatory strategy, submissions, and agency interactions for oncology therapeutics. Responsibilities: develop and execute US and ex-US regulatory plans aligned with clinical, CMC, quality, and commercial activities; serve as senior regulatory advisor to executive leadership; oversee regulatory functions, build capabilities, and manage external partners; lead successful IND and BLA filings, manage agency meetings, and ensure compliance with evolving regulations; provide updates and strategic guidance to senior stakeholders. Requirements: advanced life sciences degree (12+ years relevant experience, or 15+ years with Bachelor's), 5+ years leadership in Regulatory Affairs within biotech/pharma, proven track record with major BLA/IND submissions, deep knowledge of FDA oncology regulations, global regulatory strategy experience, and strong cross-functional collaboration skills. Preferred: experience with oncology drug development, multiple BLA approvals, and engagement with FDA/EMA. HighValue: oncology therapeutics, BLA submissions, FDA/EMA interactions, clinical to commercialization lifecycle, cross-functional leadership, and strategic regulatory planning. WorkSetup: onsite 4 days/week in Brighton, MA.