Global CMC Dossier Strategy Lead | Biologics

BioSpace; North Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie is seeking a senior professional to lead global CMC dossier preparation for novel biologics. You will coordinate cross-functional teams to ensure high-quality CMC submissions that meet global regulatory requirements, shaping strategies and influencing guidance adoption.

The role emphasizes strong regulatory writing, project leadership, and the ability to drive timely approvals across multiple complex projects.

Qualifications

• Experience preparing regulatory submissions for biologics and CMC sections.
• Strong scientific writing and data interpretation abilities.
• Ability to coordinate cross-functional teams and manage timelines.

Responsibilities

• Lead global CMC dossier coordination for biologics across phases.
• Author and coordinate CMC submission documents under regulatory timelines.
• Ensure alignment of CMC strategy with clinical/regulatory development plans.
• Mentor team members and drive cross-functional collaboration.
• Develop and maintain submission templates and best practices for CMC dossiers.

Skills

Regulatory submission experience

CMC expertise

Scientific writing

Project coordination

Communication skills

Education

Bachelor's degree

Master's degree

PhD

Job description

AbbVie is seeking a senior professional to lead global CMC dossier preparation for novel biologics. You will coordinate cross-functional teams to ensure high-quality CMC submissions that meet global regulatory requirements, shaping strategies and influencing guidance adoption.

The role emphasizes strong regulatory writing, project leadership, and the ability to drive timely approvals across multiple complex projects.