Remote Regulatory Ops & RIM Expert

Bavarian Nordic Inc.; North Carolina; Remote; USD 120,000 - 160,000; Full time

Job summary

Bavarian Nordic Inc. is seeking a Senior Expert, Regulatory Affairs Operations to maintain and optimize regulatory data systems and enable compliant global submissions. You will act as a hub for Veeva RIM and Lorenz DocuBridge, ensuring data integrity and timely, high-quality submissions across teams.

You will lead onboarding and training for users, design RIM workflows, and support cross-functional collaboration to meet global regulatory requirements and internal timelines.

Qualifications

• B.Sc./B.S. in a scientific discipline; an M.Sc. is a plus.
• Familiarity with e-submission requirements.
• Technical life science education with regulatory operations experience.
• At least 5 years’ experience in Regulatory Operations (B.Sc.) or 10 years of technical experience.

Responsibilities

• Maintain the RIM system as a Business Administrator.
• Coordinate changes to RA systems and new tools.
• Design and support RIM workflows and processes in RA.
• Create reporting and dashboards in Veeva RIM.
• Onboard/train users and provide daily RIM support to RA and cross-functional teams.
• Track submissions, objects, reports, and documents in Veeva RIM.
• Publish major/submissions in paper and electronic formats (eCTD MAAs).
• Guide teams on submission requirements and ensure regulatory compliance.

Skills

Regulatory operations

RIM systems

eCTD submissions

Veeva RIM

DocuBridge

Training & onboarding

Cross-functional collaboration

Education

B.Sc./B.S. in Life Sciences or related

M.Sc. is a plus

Tools

Lorenz DocuBridge

EMAI IRIS

Veeva RIM (tool)

DocuBridge

Job description

Bavarian Nordic Inc. is seeking a Senior Expert, Regulatory Affairs Operations to maintain and optimize regulatory data systems and enable compliant global submissions. You will act as a hub for Veeva RIM and Lorenz DocuBridge, ensuring data integrity and timely, high-quality submissions across teams.

You will lead onboarding and training for users, design RIM workflows, and support cross-functional collaboration to meet global regulatory requirements and internal timelines.