Regulatory Affairs Study Start-Up Manager

The Regulatory Affairs Study Start-Up Manager provides line management, coaching, and professional development for Regulatory Specialists and Coordinators while overseeing regulatory and study start-up activities across multiple studies and countries. This role involves regional oversight, supporting submission strategies, managing timelines and risks, and partnering with sponsors to ensure compliant and inspection-ready study execution. The position requires strong knowledge of EU regulations, ICH guidelines, and central/local submission processes in the US, Canada, and Latin America.