Job description

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Regulatory Affairs – Clinical in the United States.

This is a high-impact regulatory leadership role within a clinical-stage biotech environment focused on advancing innovative veterinary medicines. You will serve as a key authority on FDA Center for Veterinary Medicine (CVM) clinical regulatory strategy, guiding programs from early development through pivotal submissions. The role requires deep expertise in regulatory pathways, strong scientific judgment, and the ability to operate in complex, first-of-its-kind development programs with limited precedent. You will act as the primary regulatory interface with FDA CVM for clinical matters, shaping submission strategy, clinical trial compliance, and regulatory interactions. Working closely with clinical, R&D, CMC, and cross-functional teams, you will ensure regulatory alignment across all development stages. This position offers the opportunity to directly influence the approval path of groundbreaking longevity therapeutics and help define a new category in veterinary medicine.