Regulatory Submissions Associate — Project Management

Regulatory Jobs; Florham Park (NJ); Hybrid; USD 70,000 - 90,000; Full time

Job summary

AbbVie is seeking an Associate, Regulatory Affairs Submission Management to supervise low to medium impact submission projects and support cross-functional teams across development, marketing, and post-marketing regulatory activities. The role focuses on preparing content planners, coordinating publishing with vendors, and ensuring quality and compliance with regulatory guidance.

A Bachelor’s degree and two years of relevant experience are required, with preferred experience in publishing

Qualifications

• Bachelor’s degree required.
• Two years pharmaceutical or industry experience.
• Experience with publishing tools preferred.

Responsibilities

• Manages low to medium impact submission projects and ensures timely delivery of high quality dossiers.
• Provides guidance on submission processes and timelines to project teams.
• Coordinates submission publishing with offsite publishers and internal staff to meet deadlines.
• Performs detailed quality reviews of submitted content for compliance with regulatory standards.
• Contributes to process improvements within publishing and submission management.

Skills

Regulatory submissions

Regulatory affairs

Education

Bachelor’s degree

Tools

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox/DocuBridge/Insight

Adobe Acrobat

Job description

AbbVie is seeking an Associate, Regulatory Affairs Submission Management to supervise low to medium impact submission projects and support cross-functional teams across development, marketing, and post-marketing regulatory activities. The role focuses on preparing content planners, coordinating publishing with vendors, and ensuring quality and compliance with regulatory guidance.

A Bachelor’s degree and two years of relevant experience are required, with preferred experience in publishing