Sr Expert, Regulatory Affairs Operations
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, working with cross-functional teams to ensure submission-ready documents, resolve publishing issues, and deliver compliant submission packages within agreed timelines. The role administers and improves regulatory systems and processes, supports regulatory operations and lifecycle management for marketing authorization applications and other submissions, and provides training and day-to-day support to Regulatory Affairs and cross-functional colleagues. It also maintains regulatory documentation and submission processes, supports global regulatory requirements and implementation projects, and assesses AI tools for Regulatory Affairs. Working hours must align with Canadian/North American time zones. The role is remote, with East Coast candidates preferred.
Requirements
- B.Sc. in a scientific discipline; a technical education in a life science discipline together with pharmaceutical industry experience, including regulatory operations and electronic submission experience, may also be acceptable.
- At least 5 years of experience in a Regulatory Operations role with a B.Sc., or 10 years of technical experience.
- Familiarity with electronic submission requirements.
- Ability to work hours aligned with Canadian/North American time zones.
Nice To Haves
- M.Sc. degree.
Responsibilities
- Maintain the integrity of the RIM system as a Business Administrator, including serving as a back-up where needed.
- Coordinate, validate, and support major changes to Regulatory Affairs systems and implementation of new systems and tools.
- Design, optimize, maintain, and support 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 cross-functional regulatory support and advice on systems, templates, and formatting for regulatory eCTD submission components.
- Onboard new users to Lorenz DocuBridge and serve as a DocuBridge power user.
- Manage 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 and support the RIM Task Force and serve as a subject matter expert for RIM and DocuBridge.
- Administer Veeva RIM, including 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, including SOPs, work instructions, and manuals.
- 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, national competent authorities, 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
