Manager, Regulatory Affairs Submission Management - Hybrid
AbbVie
August 20, 2026
Remote friendly (North Chicago, IL)
United States
$109,500 - $208,500 USD yearly
Corporate Functions
Manager, Regulatory Affairs Submission Management
Responsibilities:
- Independently manage high-impact submission projects to deliver high-quality dossiers meeting regulatory technical specifications.
- Serve as primary RA Submissions interface with project teams; guide submission processes, standards, and technical specifications; plan/negotiation of project scope, publishing timelines, and deliverables.
- Plan and conduct submission team meetings; coordinate concurrent activities; anticipate obstacles and develop solutions.
- Coordinate submission publishing with offsite publishers; prepare content planners for publishing; resolve publishing issues with vendors; may perform in-house publishing.
- Act as technical Subject Matter Expert; troubleshoot issues and provide technical systems support; facilitate creation/procurement of submission deliverables (e.g., cover letters/forms); lead/influence without direct authority; build internal/external relationships.
- Facilitate team reviews and ensure quality review of published output (content, bookmarks, hypertext links, tables of contents) to meet regulatory standards and guidance.
- Contribute to business process and standards development; create/implement/finalize process and standards documents related to publishing deliverables.
- Suggest and implement process improvements; may recommend software/process changes; may lead/participate in internal teams updating business software.
- Manage own projects with minimal supervision; provide progress updates; provide budgetary impact estimates; train/mentor and may supervise less experienced staff.
Qualifications:
- Bachelor’s degree (or equivalent via experience).
- 6 years pharmaceutical/industry experience with publishing-related software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat) and 1–2 years cross-functional project management.
- Preferred: PMP and RAC; Regulatory Affairs experience (or QA/R&D/support/Scientific affairs/operations or related); Regulatory Operations/submission project management and/or submission publishing; proven leadership.
- Significant work activity: continuous sitting >2 consecutive hours in an 8-hour day.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees; eligible for long-term incentive programs.
Responsibilities:
- Independently manage high-impact submission projects to deliver high-quality dossiers meeting regulatory technical specifications.
- Serve as primary RA Submissions interface with project teams; guide submission processes, standards, and technical specifications; plan/negotiation of project scope, publishing timelines, and deliverables.
- Plan and conduct submission team meetings; coordinate concurrent activities; anticipate obstacles and develop solutions.
- Coordinate submission publishing with offsite publishers; prepare content planners for publishing; resolve publishing issues with vendors; may perform in-house publishing.
- Act as technical Subject Matter Expert; troubleshoot issues and provide technical systems support; facilitate creation/procurement of submission deliverables (e.g., cover letters/forms); lead/influence without direct authority; build internal/external relationships.
- Facilitate team reviews and ensure quality review of published output (content, bookmarks, hypertext links, tables of contents) to meet regulatory standards and guidance.
- Contribute to business process and standards development; create/implement/finalize process and standards documents related to publishing deliverables.
- Suggest and implement process improvements; may recommend software/process changes; may lead/participate in internal teams updating business software.
- Manage own projects with minimal supervision; provide progress updates; provide budgetary impact estimates; train/mentor and may supervise less experienced staff.
Qualifications:
- Bachelor’s degree (or equivalent via experience).
- 6 years pharmaceutical/industry experience with publishing-related software tools (e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat) and 1–2 years cross-functional project management.
- Preferred: PMP and RAC; Regulatory Affairs experience (or QA/R&D/support/Scientific affairs/operations or related); Regulatory Operations/submission project management and/or submission publishing; proven leadership.
- Significant work activity: continuous sitting >2 consecutive hours in an 8-hour day.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees; eligible for long-term incentive programs.