Sr Expert, Regulatory Affairs Operations

Sr Expert, Regulatory Affairs Operations## THIS WEBSITE USES COOKIESBavarian Nordic career site uses its own cookies. Our use of cookies is only meant to keep your session open.  You can read more about processing of your personal data here.# JOB OPENINGS## Sr Expert, Regulatory Affairs Operations Apply:
Remote:
Durham:
Full time:
Posted Yesterday:
JR101635
** 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 Docu Bridge, 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 Docu Bridge
* 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…