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. Responsibilities

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

Other duties as assigned

Qualifications

Bachelor’s degree in Pharmaceutical, Biological or related field. Master’s degree preferred.

Minimum of 4+ years’ overall experience in the biopharmaceutical/biotech industry and 3+ years of direct experience with publishing regulatory submissions.

Strong hands-on working experience with Veeva RIM systems is required.

Proven expertise in electronic submission processes (eCTD) and global regulatory requirements.

Experience with eCTD publishing tools (e.g., Veeva Publisher, docuBridge, OmniFile, etc.) and domestic/global submission gateways and portals.

Demonstrated knowledge of best practices in Veeva RIM, Veeva PromoMats, Veeva eTMF, MS Word, Excel and Adobe Acrobat in preparing submission content for eCTD submissions.

Proven ability to effectively multi-task and work under tight deadlines; must possess excellent organizational skills.

Excellent communication and interpersonal skills; must be self-motivated with eagerness to grow professionally and learn.

Ability to interpret and implement complex regulatory legislation and/or updates.

Personal attributes include:

Flexibility and integrity.

Good judgment and decision-making skills.

Action- and results-oriented.

Collaborative and team-oriented.

Occasional travel required, as needed.

Communicate effectively, including exchange of information; have regular and clear conversations.

Ability to sit; stand for prolonged periods; walk; reach with arms and hands; lift and move small objects; and use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands, and/or fingers. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of their position.