Regulatory Submissions Specialist — Publishing & Timelines

Regulatory Jobs; North Chicago (IL); On-site; USD 70,000 - 110,000; Full time

Job summary

AbbVie is seeking an Associate, Regulatory Affairs Submission Management to coordinate low to medium impact submission projects. You will establish content planners, timelines, and collaborate with cross-functional teams to deliver compliant dossiers for regulatory authorities.

Responsibilities include guiding submission processes, coordinating publishing with vendors, and ensuring quality reviews meet regulatory standards and guidelines.

Qualifications

• Bachelor’s Degree required.
• 2+ years of pharmaceutical or industry related experience.
• Experience with publishing related software tools is preferred.

Responsibilities

• Manages low to medium impact submission projects to ensure timely delivery of high quality dossiers.
• Provides input to project publishing timelines and deliverables.
• Participates in submission team meetings and coordinates multiple concurrent activities.
• Coordinates submission publishing with offsite publishers and resolves publishing issues.
• Performs detailed quality reviews to ensure compliance with regulatory standards.

Job description

AbbVie is seeking an Associate, Regulatory Affairs Submission Management to coordinate low to medium impact submission projects. You will establish content planners, timelines, and collaborate with cross-functional teams to deliver compliant dossiers for regulatory authorities.

Responsibilities include guiding submission processes, coordinating publishing with vendors, and ensuring quality reviews meet regulatory standards and guidelines.