Protecting our tomorrow
Job Title: Senior Expert, Regulatory Affairs Operations
Location: Remote, East Coast Preferred
Department: Regulatory Affairs
Reports To: Senior Manager, Regulatory Affairs Operations
Salary Range: $120k – 160k
About Bavarian Nordic
Bavarian Nordic is a global vaccine company focused on helping to protect lives through innovative vaccines, public health partnership, and expanded access to disease prevention.
We work across emerging infectious diseases, travel health, and public health preparedness to help communities, healthcare providers, pharmacies, and health systems improve vaccine awareness, access, and delivery.
With a growing commercial portfolio and strong global partnerships, Bavarian Nordic is evolving how vaccines are supported across healthcare ecosystems — combining scientific innovation with customer engagement, education, and public health impact.
Position Overview
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.
Key Responsibilities
Responsible and/or back-up for maintaining the integrity of the RIM system as a Business Administrator
Coordinate, validate and support major changes to RA systems or the implementation of new systems and tools
Design, optimize, maintain and support RIM workflows and RIM related business processes in RA
Creating Reporting and Dashboards in Veeva RIM
Responsible for onboarding and (re)training of new and existing employees to the Veeva RIM system and provision of daily support for Veeva RIM to the RA department and other cross functional departments
Responsible to track submissions/objects/applications/reports/documents in Veeva RIM and responsible for uploading all HA correspondences in Veeva RIM
Provide regulatory support and advice to cross-functional team members as needed regarding Systems, templates and formatting assistance for regulatory eCTD submission components
Responsible for Onboarding of new Users for Lorenz DocuBridge
Power User for Lorenz Docubridge
Responsible for Regulatory Operation including documentation and life-cycle management of eCTD compliant Marketing Authorization Applications (MAA) BLA and IND/CTAs Applications
Writing and maintaining Veeva RIM Quality documents (SOPs, WIs, Manuals)
Required to work hours aligned with Canadian/North American time zones
Qualifications
B.Sc. in a Scientific discipline (M.Sc. is a plus)
Familiarity with e-submission requirements
Technical education in a life science discipline together with pharmaceutical industry experience including regulatory operations (e- submission) experience can be acceptable
At least 5 years’ experience within a Regulatory Operations role with B.Sc. or 10 years of technical experience
Tasks
Coordinate RIM optimization and configuration changes, including user acceptance testing (UAT) and preparation and execution of validation test cases
Back-up/Support for 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
Responsible for data transfers and migration of Data
Train and support RA teams and other stakeholders, including super users, in Veeva RIM and mentor new RegOps team members
Independently representing Regulatory Affairs on project teams, managing submission document timelines and deliverables to meet…