Strategic CMC Dossier & Submissions Program Manager

AbbVie; Illinois; On-site; USD 120,000 - 160,000; Full time

Job summary

AbbVie in the United States is seeking a Program Manager, CMC Dossier Management to oversee regulatory submission content plans and timelines for INDs/IMPDs and marketing applications. You will coordinate with CMC RA and functional leads to ensure accurate rosters, maps, and content plans, and provide regular updates on progress.

The role requires strong cross-functional collaboration, process improvement mindset, and ability to manage multiple project plans and deadlines in a fast-paced

Qualifications

• Bachelors with CMC/related experience or higher.
• Experience supporting regulatory submission planning and content.
• Ability to create and maintain project-management tools/templates.

Responsibilities

• Support CMC projects team with content plans, source maps, rosters, and timelines.
• Coordinate diverse teams and monitor submission milestones.
• Identify process improvements and manage resource estimates.
• Provide regular updates to the CMC project team and stakeholders.

Skills

Cross-functional coordination

Project management

Regulatory submissions

Education

Bachelor's degree in CMC field

Master's degree in related field

PhD in relevant field

Job description

AbbVie in the United States is seeking a Program Manager, CMC Dossier Management to oversee regulatory submission content plans and timelines for INDs/IMPDs and marketing applications. You will coordinate with CMC RA and functional leads to ensure accurate rosters, maps, and content plans, and provide regular updates on progress.

The role requires strong cross-functional collaboration, process improvement mindset, and ability to manage multiple project plans and deadlines in a fast-paced