Senior Manager, Regulatory Affairs Operations

Job description

The Senior Manager, Regulatory Operations will report to the Director of Regulatory Operations and will be responsible for submission management across the development pipeline and support the commercial portfolio. The position will collaborate and interface with Regulatory Affairs, cross-functional teams, and related vendors to provide regulatory submission support, expertise, and overall technical guidance. The Manager, Regulatory Operations will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases. Responsibilities: Collaborate with Regulatory Affairs and cross-functional teams to plan for global health authority submissions, including overall timelines and deliverables. Manage and communicate with submission vendor on timelines and document hand-offs. Lead and support all regulatory submission types and ensuring they are compiled accurately and within specified timelines while maintaining high quality. Support the implementation of regulatory systems and tools, including migration and testing. Managing all document and submission types to be uploaded, maintained, and archived. Provid...