New · posted Nov 6
Bavarian Nordic · Biotechnology
Senior Expert, Regulatory Affairs Operations
- Remote, US, East Coast preferred
- Remote
- Full-time
- Senior & Principal
The role
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.
What you need
- 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
What you'll do
- 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
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
Pay
$120,000 a year
Employer providedProtecting 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
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.
For more information, visit www.bavarian-nordic.com
From the posting
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.
Equal opportunity, accessibility and legal noticesBavarian Nordic's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% below the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Senior & Principal roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $120,000 | — | $120,000 |
| All US (middle half) | $117,125 | $123,500 | $135,875 |
This role: Bavarian Nordic's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 40 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Bavarian Nordic's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions12
- Documentation and SOPs9
- Data and digital systems9
- Collaboration and leadership6
- Validation and qualification2
- GMP and compliance1
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Operations work in biotechnology, led by the five this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissionsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLANamed in the posting
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)Named in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Bavarian Nordic on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 2
- Locations
By discipline
- Quality2 67%
- Regulatory1 33%
By level
- Senior & Principal3 100%
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Senior Expert, Regulatory Affairs Operations at Bavarian Nordic
Open until filled. $120K a year, employer provided.