Manager, Regulatory Affairs Study Start Up (level dependent on experience)

The Regulatory Affairs Study Start-Up Manager provides line management, coaching, and professional development for Regulatory Specialists and Regulatory Coordinators while overseeing the delivery and quality of regulatory and study start-up activities across multiple studies and countries. This role provides regional oversight, supports central and local submission strategies, manages regulatory timelines and risks, and partners with sponsors and cross-functional teams to ensure compliant, timely, and inspection-ready study execution.

This position will be office based at either our headquarters located in Covington, KY or our office in Raleigh, NC.