Head of Regulatory Affairs

Head of Regulatory Affairs

About the Company

Clinical-stage biotech developing novel therapies for areas of significant unmet medical need

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is seeking a hands-on Head of Regulatory Affairs to establish and lead regulatory strategy for early-stage programs, from preclinical development through first-in-human studies and beyond. The role will serve as the primary contact with regulatory authorities and lead submissions and meeting materials, including pre-IND and IND packages and requests for scientific advice. The successful candidate will collaborate closely with clinical, CMC, and nonclinical teams, while building and scaling the regulatory function as programs advance. Candidates should have an advanced scientific degree, preferably, and progressive regulatory experience in biotechnology or pharmaceuticals. Early development experience, ideally including IND submissions and first-in-human studies, is required; experience with small-molecule development and multiple therapeutic areas is an advantage. The role calls for a strategic thinker who is also comfortable with hands-on execution, working independently or within a small, fast-moving team.

Functions

• Product Management