Manager, Regulatory Affairs - GDP

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., IN - Ds, ND - As, amendments, supplements)Manage submissions end-to-end, from planning through publishing and final delivery in partnership with Regulatory Operations. Own and drive regulatory deliverables, ensuring alignment with timelines, quality standards, and regulatory requirements. Contribute to the development and execution of regulatory strategies for assigned programs, applying regulatory knowledge and critical thinking. Interpret regulatory requirements and assess their impact on study design, submissions, and documentation. Identify regulatory risks, support development of mitigation strategies, and drive issue resolution or escalation as needed. Lead and/or facilitate cross-functional alignment and provide regulatory guidance to ensure consistency...Regulatory Affairs, Manager, Regulatory, Business Services, Alignment