Senior Manager, CMC Dossier Strategy & Submissions

AbbVie Inc.; North Chicago (IL); On-site; USD 125,000 - 237,000; Full time

Job summary

AbbVie Inc. in the United States seeks a Program Manager, CMC Dossier Management to oversee regulatory submission content plans, source document mapping, and timelines for INDs/NDAs. You will coordinate with CMC RA and functional area leads to monitor milestones and manage risks.

The role requires strong project management skills, experience in CMC late-stage development, and the ability to guide cross-functional teams through complex dossiers and audits, ensuring accuracy and timely delivery.

Qualifications

• Bachelors with 12, Masters with 10, or PhD with 4 years of CMC functional experience.
• Prior experience in a laboratory-based CMC function to assist project teams with submissions.
• Create and maintain project management tools and templates for submissions.
• Contribute to cross-functional discussions on submission risk mitigation.

Responsibilities

• Provide dossier support including content plans, source maps, rosters, and timelines.
• Coordinate with CMC RA and leads to monitor milestones and risks.
• Identify process improvements and drive action on defined objectives.
• Apply PM principles to coordinate goals and track progress.
• Provide updates to the team on submission progress and changes.
• Assist with training and governance of project management practices.
• Build network with internal and external stakeholders across the department.

Skills

CMC project management

Regulatory submissions

Cross-functional coordination

Root cause analysis

Risk mitigation

Project scheduling

Education

Bachelor's degree in a relevant field

Master's degree in a related field

PhD in a related field

Job description

AbbVie Inc. in the United States seeks a Program Manager, CMC Dossier Management to oversee regulatory submission content plans, source document mapping, and timelines for INDs/NDAs. You will coordinate with CMC RA and functional area leads to monitor milestones and manage risks.

The role requires strong project management skills, experience in CMC late-stage development, and the ability to guide cross-functional teams through complex dossiers and audits, ensuring accuracy and timely delivery.