Senior Associate Regulatory Affairs Submission Management (Hybrid)
AbbVie
June 25, 2026
Remote friendly (North Chicago, IL)
United States
$84,500 - $162,000 USD yearly
Corporate Functions
Responsibilities:
- Manage medium to high impact, moderately complex regulatory submission projects to ensure timely delivery of high-quality dossiers meeting regulatory technical specifications.
- Serve as the RA Submissions interface with project teams; provide guidance on submission processes/standards and input to project scope impacting publishing timelines and deliverables.
- Plan and conduct submission team meetings; coordinate concurrent interrelated activities; anticipate obstacles and develop solutions.
- Coordinate submission publishing with offsite publishers; prepare content planners for publishing; work with vendors to resolve publishing issues; may perform in-house publishing.
- Act as a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
- Facilitate creation or procurement of submission content deliverables (e.g., cover letters and forms).
- Perform detailed quality reviews of published output (content, bookmarks, hypertext links, tables of contents) for compliance with Regulatory Standards and Health Authority guidance.
- Suggest and contribute to process improvements (software/business processes); may update internal business software.
- Demonstrate team leadership and ability to influence without direct authority; build and maintain relationships.
- Develop and implement internal process/standards documents relating to publishing and publishing deliverables; train and mentor less experienced staff.
Qualifications:
- Bachelor’s degree.
- 4+ years pharmaceutical or industry-related experience with publishing software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat).
- Proven leadership skills and presence.
- Preferred: PMP and RAC certificates.
- Preferred: Regulatory Affairs experience (or related QA/R&D/support/Scientific affairs/operations).
- Preferred: Regulatory Operations experience, including regulatory submission project management and/or submission publishing.
- Manage medium to high impact, moderately complex regulatory submission projects to ensure timely delivery of high-quality dossiers meeting regulatory technical specifications.
- Serve as the RA Submissions interface with project teams; provide guidance on submission processes/standards and input to project scope impacting publishing timelines and deliverables.
- Plan and conduct submission team meetings; coordinate concurrent interrelated activities; anticipate obstacles and develop solutions.
- Coordinate submission publishing with offsite publishers; prepare content planners for publishing; work with vendors to resolve publishing issues; may perform in-house publishing.
- Act as a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
- Facilitate creation or procurement of submission content deliverables (e.g., cover letters and forms).
- Perform detailed quality reviews of published output (content, bookmarks, hypertext links, tables of contents) for compliance with Regulatory Standards and Health Authority guidance.
- Suggest and contribute to process improvements (software/business processes); may update internal business software.
- Demonstrate team leadership and ability to influence without direct authority; build and maintain relationships.
- Develop and implement internal process/standards documents relating to publishing and publishing deliverables; train and mentor less experienced staff.
Qualifications:
- Bachelor’s degree.
- 4+ years pharmaceutical or industry-related experience with publishing software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat).
- Proven leadership skills and presence.
- Preferred: PMP and RAC certificates.
- Preferred: Regulatory Affairs experience (or related QA/R&D/support/Scientific affairs/operations).
- Preferred: Regulatory Operations experience, including regulatory submission project management and/or submission publishing.