Regulatory Document Coordinator, Regulatory Affairs US- Remote

Assist in managing the activities of external publishing staff contracted to publish and dispatch health authority submissions.

Manage document-related tasks including internal workflow management, file transfer, tracking, and archival.

Communicate and provide deliverables to Medical Writers, Quality, Regulatory Leads and others as applicable.

Manage submission archival for ongoing regulatory submissions.

Maintain and update trackers, correspondence logs, and metrics, as needed, to support the Regulatory Team.

File Regulatory correspondence in the Regulatory Information Management (RIM) system.

Assist in Veeva RIM management activities.

Serve as the internal subject matter expert (SME) for Accenture Formatting Tool, as a resource for Regulatory and cross-functional authoring teams.

Assist in maintaining regulatory document template library.