Regulatory Submissions Lead, Publishing & Compliance

AbbVie Inc.; North Chicago (IL); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie is seeking a Senior Associate, Regulatory Affairs Submission Management to lead medium to high impact submission projects. You will coordinate cross-functional teams, manage content planners, and interface with publishing vendors to ensure timely delivery of compliant dossiers.

The role requires 4 years in pharma/regulatory publishing and experience with publishing tools. Hybrid work is available from North Chicago, IL or Florham Park, NJ with a mix of in-office and remote days.

Qualifications

• 4 years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.

Responsibilities

• Manages medium to high impact submission projects to ensure timely delivery of high-quality dossiers that meet regulatory standards.
• Acts as RA Submissions interface with project teams, guiding submission processes and publishing timelines.
• Plans and conducts submission team meetings and coordinates activities to meet publishing deadlines.
• Coordinates submission publishing with offsite publishers and vendors to resolve issues and ensure timely publication.

Skills

Regulatory affairs

Project management

Team leadership

Cross-functional collaboration

Education

Bachelor’s degree

Tools

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox/DocuBridge/Insight

Adobe Acrobat

Job description

AbbVie is seeking a Senior Associate, Regulatory Affairs Submission Management to lead medium to high impact submission projects. You will coordinate cross-functional teams, manage content planners, and interface with publishing vendors to ensure timely delivery of compliant dossiers.

The role requires 4 years in pharma/regulatory publishing and experience with publishing tools. Hybrid work is available from North Chicago, IL or Florham Park, NJ with a mix of in-office and remote days.