Remote Senior Expert, Regulatory Operations & Submissions

Bavarian Nordic; Durham (NC); Remote; USD 120,000 - 160,000; Full time

Job summary

Bavarian Nordic seeks a Senior Expert, Regulatory Affairs Operations to safeguard regulatory data integrity, optimize workflows, and publish global submissions in eCTD and non-eCTD formats.

In this remote-enabled role, you will coordinate RA systems, maintain Veeva RIM and DocuBridge, train colleagues, and ensure timely, compliant submissions across FDA, EMA, and other authorities. Collaboration with cross-functional teams is essential.

Qualifications

• B.Sc. in a Scientific discipline (M.Sc. is a plus).
• Familiarity with e-submission requirements (FDA/EMA).
• 5+ years in Regulatory Operations (or 10+ years technical experience).

Responsibilities

• Coordinate RIM optimization and configuration changes, including UAT and validation test cases.
• Administer Veeva RIM, including master data, user access, value lists, templates and workflows.
• Publish major/global submissions in paper and electronic formats (eCTD MAAs, eIND).
• Train and support RA teams in Veeva RIM and DocuBridge; mentor new RegOps members.
• Track submissions/documents and ensure compliance with international guidelines.

Skills

Veeva RIM Expertise

DocuBridge Proficiency

Regulatory Submissions

Cross-functional Collaboration

UAT & Validation Testing

Education

B.Sc. in Life Sciences

M.Sc. in Life Sciences (preferred)

Tools

Veeva RIM

Lorenz DocuBridge

eCTD Publisher tools

Job description

Bavarian Nordic seeks a Senior Expert, Regulatory Affairs Operations to safeguard regulatory data integrity, optimize workflows, and publish global submissions in eCTD and non-eCTD formats.

In this remote-enabled role, you will coordinate RA systems, maintain Veeva RIM and DocuBridge, train colleagues, and ensure timely, compliant submissions across FDA, EMA, and other authorities. Collaboration with cross-functional teams is essential.