Regulatory Ops Expert - RIM & Submissions (Remote)

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

Job summary

Bavarian Nordic seeks a Senior Expert in Regulatory Affairs Operations to safeguard regulatory data, optimize workflows, and support global submissions using Veeva RIM and Lorenz DocuBridge. You will train staff, ensure compliant eCTD documents, and lead RA system improvements.

You will coordinate cross-functional teams across North American time zones, publish submissions, and maintain quality documents while advancing AI tool assessments within RA.

Qualifications

• B.Sc. in a scientific discipline; M.Sc. is a plus.
• Familiarity with e-submission requirements.
• Experience in Regulatory Operations focusing on e-submissions.
• At least 5 years in Regulatory Operations with a B.Sc. or 10 years of technical experience.

Responsibilities

• Maintain RIM data integrity and act as Business Administrator.
• Coordinate major RA system changes and new tool implementations.
• Design and support RIM workflows and related business processes.
• Create reports and dashboards in Veeva RIM.

Skills

Veeva RIM experience

Regulatory operations

Cross-functional collaboration

Documentation & SOPs

RA system training

Education

B.Sc. in Life Science

Tools

Veeva RIM

Lorenz DocuBridge

eCTD submissions

Job description

Bavarian Nordic seeks a Senior Expert in Regulatory Affairs Operations to safeguard regulatory data, optimize workflows, and support global submissions using Veeva RIM and Lorenz DocuBridge. You will train staff, ensure compliant eCTD documents, and lead RA system improvements.

You will coordinate cross-functional teams across North American time zones, publish submissions, and maintain quality documents while advancing AI tool assessments within RA.