Senior Regulatory Submissions Lead (Hybrid)

AbbVie; North Chicago (IL); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work schedule

Job summary

AbbVie is hiring a Senior Associate, Regulatory Affairs Submission Management to lead medium-to-high impact submission projects. You will establish timelines, coordinate cross-functional teams, and manage content planning for regulatory filings across development, marketing and post-marketing applications.

You will work a hybrid schedule (3 days in office, 2 days remote) from AbbVie's North Chicago, IL or Florham Park, NJ campuses.

Qualifications

• Bachelor’s degree required; years of experience may compensate.
• 4 years’ pharmaceutical or industry experience with publishing-related software tools.
• PMP and RAC certificates are a plus

Responsibilities

• Manage medium to high impact submission projects to ensure timely delivery of high-quality dossiers.
• Serve as RA submissions interface with project teams, guiding publishing timelines and deliverables.
• Plan and conduct submission team meetings and coordinate publishing activities.
• Coordinate publishing with offsite publishers and internal teams; resolve publishing issues.
• May provide SME-level technical system support as needed.
• Facilitate creation of submission content deliverables such as cover letters and forms.
• Perform detailed quality reviews of published output to ensure regulatory compliance.

Skills

Regulatory affairs

Submission management

Project coordination

Cross-functional collaboration

Education

Bachelor's degree

Tools

Documentum

eCTDXPress/ISIPublisher

ISIToolbox/DocuBridge/Insight

Adobe Acrobat

Job description

AbbVie is hiring a Senior Associate, Regulatory Affairs Submission Management to lead medium-to-high impact submission projects. You will establish timelines, coordinate cross-functional teams, and manage content planning for regulatory filings across development, marketing and post-marketing applications.

You will work a hybrid schedule (3 days in office, 2 days remote) from AbbVie's North Chicago, IL or Florham Park, NJ campuses.