Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. This role is responsible for managing the preparation, quality control, publishing, dispatch, and archival of all regulatory submissions within the Veeva RIM system, ensuring compliance with regulations, SOPs, and internal standards.
Requirements
- Manage the coordination and publishing of submissions to regulatory Health Authorities in the appropriate eCTD format using Veeva RIM
- Monitor submission timelines and proactively identify risks or delays, leveraging Veeva RIM dashboards and reporting tools for visibility and tracking
- Provide training and guidance to regulatory staff on Veeva RIM functionality and best practices
- Implement and optimize Veeva RIM workflows to streamline submission processes and improve operational efficiency
- Maintain accurate, audit-ready records and metadata within Veeva RIM to support regulatory compliance and inspection readiness
- Provide support to Regulatory Staff by processing submission objects and content plans within Veeva RIM, ensuring proper document formatting, and incorporating bookmarks and hyperlinks as required
- Archive regulatory submissions and correspondences; process submission metrics and reports as necessary
- Collaborate with QA, IT, and/or 3rd parties to ensure Veeva RIM, Omnicia, docuBridge, etc. system configurations meet evolving regulatory and business needs
- Maintain regulatory chronologies and trackers as needed
- Maintain current knowledge of existing and emerging regulations, standards, or guidance’s related to electronic submission and publishing requirements
- Provide support in the development of standard operational procedures, work instructions, and systems to ensure regulatory compliance
- Coordinate with external partners for operational deliverables including support of publishing and/or Veeva RIM on and off boarding
- Manage and resolve publishing-related issues encountered during validation as needed
- Maintain regulatory submission tracking reports for CRB and MRB
- Maintain clinical trial regulatory compliance tracking for ongoing development programs
- Establish and maintain the regulatory archive in the eTMF Veeva Vault structure as necessary
- Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork
Benefits
- Full range of health and welfare insurance benefits
- 401(k) company match
- Paid time off benefits, including 17 paid holidays in 2025
