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Dynavax Technologies · 1 month ago

Manager, Regulatory Operations

Emeryville, CA

Full-time

Hybrid

Mid, Senior Level

$132K/yr - $150K/yr

4+ years exp

Dynavax Technologies is a commercial-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The Manager of Regulatory Operations will oversee the regulatory submission process, ensuring compliance with regulations and internal standards while managing a team responsible for electronic regulatory filings.

BiopharmaBiotechnologyClinical TrialsHealth CareMedical Device

Work & Life Balance

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

Qualification

Veeva RIM systemsECTD submission processesECTD publishing toolsRegulatory complianceOrganizational skillsCommunication skillsTeam-orientedFlexibilityIntegrity

Required

Bachelor's degree in Pharmaceutical, Biological or related field

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

Flexibility and integrity

Good judgment and decision-making skills

Action- and results-oriented

Collaborative and team-oriented

Occasional travel required, as needed

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