Manager, Regulatory Operations
Dynavax Technologies
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $132,000 - $150,000 per year
Job Level
Mid-LevelSenior
Tech Stack
Vault
About the role
- 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
Requirements
- 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.
Benefits
- Health insurance
- 401(k) company match
- Paid time off
- 17 paid holidays in 2025
- Flexible work environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Veeva RIMeCTDelectronic submission processespublishing regulatory submissionsVeeva PublisherdocuBridgeOmniFileMS WordExcelAdobe Acrobat
Soft skills
organizational skillscommunication skillsinterpersonal skillsmulti-taskingself-motivatedeagerness to growability to work under tight deadlines