Senior Associate Regulatory Affairs Submission Management - Hybrid
AbbVie
August 20, 2026
Remote friendly (North Chicago, IL)
United States
$78,500 - $141,000 USD yearly
Operations
Senior Associate, Regulatory Affairs Submission Management
Responsibilities:
- Manage medium to high impact, moderately complex regulatory submission projects to deliver high-quality dossiers meeting regulatory technical specifications.
- Serve as RA Submissions interface with project teams; guide submission processes/standards and provide input to project scope affecting publishing timelines/deliverables.
- Plan and run submission team meetings; coordinate concurrent submission activities, anticipate obstacles, and develop solutions.
- Coordinate submission publishing with offsite publishers; prepare content planners for publishing, work with vendors to resolve publishing issues, and may perform in-house publishing.
- Troubleshoot submission publishing/system issues as a technical subject matter expert.
- Facilitate creation/procurement of submission content (e.g., cover letters, forms).
- Conduct detailed quality reviews of published outputs (content, bookmarks, hypertext links, tables of content) and facilitate team reviews.
- Suggest process improvements (software/business processes), contribute to department standards/process documents, and mentor/train less experienced staff.
- Hybrid schedule: 3 days in office & 2 days remote (North Chicago, IL).
Qualifications:
- Bachelor’s degree (years of experience may compensate).
- Required experience: 4 years pharmaceutical/industry experience with publishing-related software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight, Adobe Acrobat).
- Preferred: PMP and RAC; Regulatory Affairs (or QA/R&D/support/scientific affairs/operations related); Regulatory Operations and submission project management/publishing; proven leadership skills.
Benefits (as stated): paid time off, medical/dental/vision insurance, 401(k), and eligibility for short-term incentive programs.
Responsibilities:
- Manage medium to high impact, moderately complex regulatory submission projects to deliver high-quality dossiers meeting regulatory technical specifications.
- Serve as RA Submissions interface with project teams; guide submission processes/standards and provide input to project scope affecting publishing timelines/deliverables.
- Plan and run submission team meetings; coordinate concurrent submission activities, anticipate obstacles, and develop solutions.
- Coordinate submission publishing with offsite publishers; prepare content planners for publishing, work with vendors to resolve publishing issues, and may perform in-house publishing.
- Troubleshoot submission publishing/system issues as a technical subject matter expert.
- Facilitate creation/procurement of submission content (e.g., cover letters, forms).
- Conduct detailed quality reviews of published outputs (content, bookmarks, hypertext links, tables of content) and facilitate team reviews.
- Suggest process improvements (software/business processes), contribute to department standards/process documents, and mentor/train less experienced staff.
- Hybrid schedule: 3 days in office & 2 days remote (North Chicago, IL).
Qualifications:
- Bachelor’s degree (years of experience may compensate).
- Required experience: 4 years pharmaceutical/industry experience with publishing-related software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight, Adobe Acrobat).
- Preferred: PMP and RAC; Regulatory Affairs (or QA/R&D/support/scientific affairs/operations related); Regulatory Operations and submission project management/publishing; proven leadership skills.
Benefits (as stated): paid time off, medical/dental/vision insurance, 401(k), and eligibility for short-term incentive programs.