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.
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.
Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases.
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.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.
The Upstream Senior Clinical Program Manager will design and execute pre-market feasibility and pivotal clinical studies, ensuring regulatory compliance while supporting marketing claims. This role requires close collaboration with physician collaborators and internal stakeholders to collect, analyze, and interpret clinical data. The role offers remote flexibility, with occasional travel for on-site meetings and conferences.
This position is posted by Jobgether on behalf of a partner company.
Lead global regulatory activities for cell therapy programs as the Global Regulatory Lead. Shape regulatory strategy, lead health authority interactions, and support documentation. Collaborate with Clinical, CMC, Nonclinical, Quality, and Program Management teams.
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases.