Sr Expert, Regulatory Affairs Operations

Job description

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