Manager, Regulatory Operations (Remote)

The Manager, Regulatory Operations provides operational leadership for the Regulatory Operations function across START USA, leading and developing a team to ensure timely, accurate, and compliant regulatory submissions. This role oversees day-to-day regulatory operations, maintains relationships with IRBs, Sponsors, and CROs, and serves as the main point of contact for complex regulatory issues. The position is responsible for process standardization, metrics monitoring, and continuous improvement of systems and workflows supporting IRB, IBC, and FDA interactions.