Sr Expert, Regulatory Affairs Operations

Bavarian Nordic • Durham, NC

1d • Remote

About The Position

The Senior Expert, Regulatory Affairs Operations plays a key role in maintaining reliable regulatory systems and enabling efficient, compliant global submissions at Bavarian Nordic. As a business administrator and subject matter expert for Veeva RIM and Lorenz DocuBridge, this role safeguards regulatory data integrity, optimizes workflows, and supports system enhancements, user training, and cross-functional collaboration.

The position coordinates, compiles, verifies, and publishes global regulatory submissions in eCTD and non-eCTD formats. It works with cross-functional teams to ensure submission-ready documents, resolve publishing issues, and deliver compliant submission packages within agreed timelines. The role also supports regulatory operations, submission lifecycle management, and implementation of regulatory systems and tools.

Requirements

• Bachelor of Science in a scientific discipline; a master’s degree is a plus.
• Familiarity with electronic submission requirements.
• At least 5 years of experience in a Regulatory Operations role with a B.Sc., or 10 years of technical experience.
• Technical education in a life science discipline together with pharmaceutical industry experience, including regulatory operations (e-submission) experience, may be acceptable.

Nice To Haves

• Master’s degree in a scientific discipline.
• East Coast location is preferred.

Responsibilities

• Maintain the integrity of the Veeva RIM system as a business administrator or backup.
• Coordinate, validate, and support major changes to regulatory affairs systems and implementation of new systems and tools.
• Design, optimize, maintain, and support Veeva RIM workflows and related regulatory affairs business processes.
• Create reports and dashboards in Veeva RIM.
• Onboard and retrain employees on Veeva RIM and provide daily system support to Regulatory Affairs and cross-functional departments.
• Track submissions, objects, applications, reports, and documents in Veeva RIM, and upload Health Authority correspondence.
• Provide regulatory systems support and advice, including templates and formatting assistance for eCTD submission components.
• Onboard new users to Lorenz DocuBridge and serve as a DocuBridge power user.
• Perform regulatory operations, including documentation and lifecycle management of eCTD-compliant MAA, BLA, and IND/CTA applications.
• Write and maintain Veeva RIM quality documents, including SOPs, work instructions, and manuals.
• Coordinate RIM optimization and configuration changes, including user acceptance testing and preparation and execution of validation test cases.
• Back up or support the RIM Task Force and serve as a subject matter expert for RIM and DocuBridge.
• Administer Veeva RIM master data, user access, value lists, templates, and workflows.
• Manage data transfers and data migration.
• Train and support Regulatory Affairs teams and other stakeholders, including super users, in Veeva RIM, and mentor new Regulatory Operations team members.
• Represent Regulatory Affairs independently on project teams and manage submission document timelines and deliverables to meet global submission plans.
• Establish and maintain Regulatory Affairs submission processes and RIM-related quality documents.
• Coordinate, compile, verify, and publish major and routine global submissions in paper and electronic formats, including eIND, eCTD MAAs, and non-eCTD submissions.
• Guide cross-functional teams and document authors on submission requirements, resolve publishing issues, and ensure compliance with international guidelines, company templates, authoring standards, and Veeva workflows.
• Track, file, and archive regulatory documents, submissions, and Health Authority correspondence in Veeva RIM within required timeframes.
• Maintain current knowledge of controlled-document and electronic-submission requirements established by the FDA, EMA, Health Canada, NCAs, and ICH.
• Support or back up IDMP and DADI/eAF implementation projects and support and coordinate the Regulatory Affairs IDMP and eAF groups.
• Administer EMA systems, including IRIS, SPOR, and PLM.
• Assess and support implementation of AI tools within Regulatory Affairs.
• Work hours aligned with Canadian/North American time zones.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior