Hybrid Regulatory Submissions Lead - Projects & Publishing

Regulatory Jobs; North Chicago (IL); Hybrid; USD 90,000 - 120,000; Full time

Job summary

AbbVie, a global biopharmaceutical company, is seeking a Senior Associate in Regulatory Affairs Submission Management. The role coordinates cross-functional teams to deliver regulatory submissions, maintains content planners, and interfaces with publishing vendors to ensure timely, compliant dossiers for development, marketing, and post-marketing programs.

This position emphasizes leadership, mastery of publishing tools, and strong communication with project teams.

Qualifications

• Bachelor’s degree required.
• Four years’ pharmaceutical or industry experience with publishing tools.
• Experience with publishing software such as Documentum and ISI Publisher is preferred.

Responsibilities

• Manages medium to high impact submission projects to ensure timely delivery of high-quality dossiers.
• Acts as RA Submissions interface with project teams providing guidance on submission processes and standards.
• Plans and conducts submission team meetings and coordinates multiple activities to meet publication timelines.

Skills

Leadership

Regulatory submissions

Project coordination

Cross-functional collaboration

Education

Bachelor’s degree

PMP

RAC

Tools

Documentum

ISIPublisher/eCTDXPress

ISI Toolbox/DocuBridge/Insight

Adobe Acrobat

Job description

AbbVie, a global biopharmaceutical company, is seeking a Senior Associate in Regulatory Affairs Submission Management. The role coordinates cross-functional teams to deliver regulatory submissions, maintains content planners, and interfaces with publishing vendors to ensure timely, compliant dossiers for development, marketing, and post-marketing programs.

This position emphasizes leadership, mastery of publishing tools, and strong communication with project teams.