Sr Expert, Regulatory Affairs Operations

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

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 OperationsApply: 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 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 global submission plans* Establish and maintain BN-RA submission processes and RIM-related quality documents, including SOPs, work instructions and manuals* Coordinate, compile, verify and publish major and routine global submissions in paper and electronic formats, including eIND, eCTD MAAs and non-eCTD submissions* Guide cross-functional teams and document authors on submission requirements, resolving publishing issues and ensuring compliance with international guidelines, BN templates, authoring standards and Veeva workflows* Track, file and archive regulatory documents, submissions and Health Authority correspondence in Veeva RIM within required timeframes* Maintain current knowledge of controlled document and electronic submission requirements established by the FDA, EMA, Health Canada, NCAs and ICH* Support/ back-up for IDMP and DADI/eAF implementation projects and support and coordinate the RA IDMP and eAF groups* Administer EMA systems, including IRIS, SPOR and PLM* Assess and support the implementation of AI tools within RA **Why Join Us** Join a mission-driven global vaccine company at a pivotal stage of growth and evolution. At Bavarian Nordic, you’ll have the opportunity to help shape innovative commercial programs, support public health initiatives, and contribute to how vaccines are accessed across healthcare channels. We foster a collaborative, entrepreneurial culture where cross-functional partnership, creativity, and impact are valued alongside scientific excellence. Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. For more information, visit *www.bavarian-nordic.com* *#LI-MA1*Join Bavarian Nordic a fully integrated vaccine company focused on the development, manufacturing and commercialization of life-savings vaccines*Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic!**Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against on the basis of race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.**For more information visit* www.bavarian-nordic.com