Manager, Regulatory Affairs - GDP

Job description

Overview The Manager, Regulatory Affairs – Global Development supports development and lifecycle regulatory activities across assigned products and clinical programs. This role serves as the Regulatory Affairs lead for assigned projects, owning regulatory deliverables and acting as a key point of contact for cross-functional teams. The individual operates with a high degree of autonomy for assigned responsibilities, applying regulatory knowledge and critical thinking to interpret data, ensure compliance, and guide regulatory activities with minimal direction. This role contributes to regulatory strategy execution and proactively identifies risks, drives solutions, and escalates as needed to support successful regulatory outcomes. Responsibilities: - Serve as the Regulatory Affairs lead for assigned clinical programs and submissions, acting as the primary point of contact for regulatory activities - Lead preparation, organization, and QC review of regulatory submissions (e.g., INDs, NDAs, amendments, supplements) - Manage submissions end-to-end, from planning through publishing and final delivery in partnership with Regulatory Operations - Own and drive regulatory deliverables, ensu...