Head of Regulatory Affairs

About the Company: Specialty biotech company with approved rare disease product and active Phase 3 program Industry Biotechnology Type Privately HeldAbout the RoleThe Company is seeking a Head of Regulatory Affairs to lead U.S. regulatory strategy for development and approved programs. The role will serve as the primary point of contact with regulatory authorities, including preparing for and leading agency meetings. Responsibilities include writing and reviewing clinical and nonclinical submission sections, preparing briefing packages and responses, and leading submissions and expedited pathway requests. The successful candidate will collaborate with cross-functional teams, monitor regulatory developments, and maintain organized records and correspondence. Candidates should hold an advanced degree in a life sciences field and have at least 15 years of regulatory affairs experience in biotechnology or pharmaceuticals. Required experience includes leading regulatory agency meetings, contributing to product approvals, preparing clinical and nonclinical documents, and working on applications and orphan drug designations. Strong scientific writing, communication, and organizational skills are essential, along with the ability to work hands-on within a small team. Hiring Manager Title CEOFunctionsProduct Management