Senior CMC Dossier Program Lead

AbbVie Inc.; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie Inc. in North Chicago is seeking a Program Manager, CMC Dossier Management to lead and oversee CMC regulatory deliverables, including INDs/IMPDs and marketing applications, using standardized project management tools.

You will map source documents, maintain rosters and timelines, coordinate cross-functional teams, and drive process improvements while ensuring on-time submissions and accurate content plans.

Qualifications

• Bachelor's degree with 12 years or Master's with 10 years or PhD with 4 years in CMC functional experience.
• Prior experience in a laboratory-based CMC function to support submission planning.
• Create and maintain project management tools/templates for submissions.
• Contribute to cross-functional discussions on submission-risk mitigation.

Responsibilities

• Monitor progress of regulatory submissions against timelines.
• Map and track source information supporting submission sections.
• Maintain rosters and timelines for multiple projects.
• Provide dossier support including content plans and source documents.
• Collaborate with CMC RA and leads; assist with resource estimates.
• Identify opportunities to improve departmental processes and projects.
• Coordinate activities to meet defined objectives and milestones.
• Provide updates to the team on submission progress and changes.

Skills

CMC project management

Regulatory submissions

Cross-functional coordination

Process improvement

Education

Bachelor's or higher in relevant field

Master's degree preferred

PhD with experience considered

Job description

AbbVie Inc. in North Chicago is seeking a Program Manager, CMC Dossier Management to lead and oversee CMC regulatory deliverables, including INDs/IMPDs and marketing applications, using standardized project management tools.

You will map source documents, maintain rosters and timelines, coordinate cross-functional teams, and drive process improvements while ensuring on-time submissions and accurate content plans.