Manager, Regulatory Operations

This position can be 100% remote, but must be located in the United States.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment of public health. Our proprietary CpG 1018 adjuvant powers our diversified infectious vaccine portfolio, which includes HEPLISAV-B®, our commercial product approved in the U.S. and the European Union, for prevention of hepatitis B virus in adults.

We also supply CpG 1018 to research collaborations and partnerships globally. Currently, CpG 1018 is being used in development of COVID-19, plague, shingles, and Tdap vaccines.

At Dynavax, our vision and work ethic are guided by the collective ideals underpinning our core values, and these form the basis of our dynamic company culture. We strive to maintain a culture where each employee is valued by the organization and where our organization is valued by each employee. We offer a highly flexible work environment for our headquarter employees where individuals work remotely and gather for in-person meetings when necessary.

Dynavax is headquartered in the San Francisco Bay area, and our manufacturing facility is in Düsseldorf, Germany.

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. The Manager of Regulatory Operations will support Regulatory staff in coordinating and processing electronic regulatory filings across internal and external sources including but not limited to CMC, labeling, clinical, administrative, pharmacovigilance, and/or advertising and promotional material submissions.

The Manager of Regulatory Operations oversees the regulatory submission process for all assigned projects and products throughout their lifecycle. This individual provides critical support to the Regulatory Department to facilitate efficient and compliant business practices. Additionally, the role is responsible for implementing and maintaining effective Veeva RIM and publishing systems, ensuring submissions adhere to established quality standards.

• 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, docu Bridge, 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…