Senior Regulatory Submissions Manager

Regulatory Jobs; North Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Job summary

AbbVie is seeking a Manager, Regulatory Affairs Submission Management to lead high-impact submission projects across Development, Marketing, and post-marketing programs. You will establish timelines, coordinate cross-functional teams, and interface with publishing vendors to deliver high-quality dossiers on time.

You will act as a subject-matter expert in submission management, guiding project scope, planning, and execution while ensuring compliance with regulatory standards and best practices

Qualifications

• Bachelor’s degree required; years of experience may compensate.
• 6 years’ pharmaceutical or industry experience with publishing software tools.
• Experience in project management within regulatory submissions.
• Knowledge of publishing standards and regulatory expectations.

Responsibilities

• Independently manages high impact submission projects to ensure timely delivery of high-quality dossiers meeting regulatory specifications.
• Acts as primary RA Submissions interface with project teams guiding submission processes, standards and timelines.
• Plans and negotiates submission scope, publishing timelines and deliverables with stakeholders.
• Plans and conducts submission team meetings and coordinates multiple activities to meet deadlines.
• Coordinates publishing with offsite publishers and vendors to resolve issues and ensure resources are available.
• Leads or participates on internal project teams to update business software and processes.

Skills

Team leadership

Cross-functional collaboration

Project management

Education

Bachelor's degree

Tools

Documentum

eCTDXPress/ISIPublisher

ISI Toolbox/DocuBridge/Insight

Adobe Acrobat

Job description

AbbVie is seeking a Manager, Regulatory Affairs Submission Management to lead high-impact submission projects across Development, Marketing, and post-marketing programs. You will establish timelines, coordinate cross-functional teams, and interface with publishing vendors to deliver high-quality dossiers on time.

You will act as a subject-matter expert in submission management, guiding project scope, planning, and execution while ensuring compliance with regulatory standards and best practices