Responsible for managing the preparation, quality control, publishing, dispatch, and archival of all regulatory submissions within the Veeva RIM system. Oversees the regulatory submission process for all assigned projects and products throughout their lifecycle. Provides training and guidance to regulatory staff on Veeva RIM functionality and best practices.
Source Job
2 jobs similar to Manager, Regulatory Operations
Jobs ranked by similarity.
The Regulatory Document Coordinator will have primary responsibility for document management activities supporting Regulatory Affairs. Key responsibilities include word formatting, PDF publishing, eCTD output review, submission archival, and document workflow management. This position will play an integral role in the execution of the Regulatory strategy world-wide, with multiple avenues for continued development.
Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care
- Prepare and compile regulatory dossiers for international markets.
- Coordinate and review administrative and technical documentation for new product registrations.
- Manage regulatory documents and data within Veeva Vault RIM.
BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases.