Head of Regulatory Affairs

Head of Regulatory Affairs About the OpportunityWe're partnering with a clinical-stage biotech in Cambridge developing therapies in metabolic and liver disease. As the company builds its local presence and brings more development activities in-house, it's seeking an experienced regulatory leader to own and run the regulatory function.This is a hands-on leadership role for someone who has worn many hats. You'll bring the discipline of the core regulatory process, the judgment that comes from taking programs through Phase 1 to Phase 3, and the ability to build the function as the company grows.What You'll Do Own and lead the regulatory affairs function, including day-to-day operations, submissions, and agency interactions Set and execute regulatory strategy across the clinical portfolio, partnering closely with Clinical, CMC, and executive leadership Plan, prepare, and manage regulatory submissions (INDs, amendments, annual reports, briefing packages, and late-stage filings), working with internal teams and external partners Serve as the primary point of contact with FDA and other health authorities, leading meeting preparation and communications Manage regulatory vendors and CRO partners, and lead the transition of regulatory activities and knowledge in-house Support quality and GxP compliance activities as they relate to regulatory submissions and clinical programs Build the regulatory SOPs, processes, and infrastructure the function needs as the company scales Monitor the regulatory and competitive landscape in metabolic and liver disease and advise leadership on implicationsWhat You Bring Bachelor's degree required; advanced degree (MS, PharmD, PhD) preferred 10+ years of regulatory affairs experience in biotech/pharma, including leading a regulatory function or group Demonstrated experience taking a program through Phase 1, Phase 2, and Phase 3 clinical development Direct experience leading FDA interactions and managing CROs and regulatory vendors Working knowledge of GxP and quality requirements, with the ability to support quality activities as needed Experience in obesity, metabolic, or liver disease is a plus Comfortable in a lean, fast-moving environment where you'll be both strategic and hands-on Available full-time (40 hours/week) Able to be onsite in Cambridge at least 2 days per week