Global CMC Dossier Strategy Lead

AbbVie; North Chicago (IL); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Paid time off

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Job summary

AbbVie seeks a seasoned regulatory leader to drive global CMC dossier preparation for novel synthetic molecules, coordinating cross-functional teams of subject matter experts to ensure high-quality regulatory submissions. The role focuses on aligning CMC submission strategy with clinical and regulatory development goals, while implementing efficient processes and maintaining up-to-date control strategies.

The incumbent will guide dossier authors, refine submission templates, and mentor team

Qualifications

• Bachelor’s level education in a relevant field with advanced degrees preferred
• Experience leading regulatory submissions and document preparation for CMC in late-stage development
• Strong written and verbal communication, with ability to summarize complex data for regulatory authorities

Responsibilities

• Author and coordinate submission documentation for all phases of clinical development with emphasis on late-stage programs
• Lead global cross-functional CMC Team to prepare and review regulatory submission documents
• Mentor and guide dossier authors; build and maintain submission templates with CMC Regulatory
• Develop and implement standard processes for CMC submission planning, drafting, review and approval

Skills

Leadership

Regulatory Writing

Cross-functional

Communication

Project Management

Independent Work

Education

Bachelor’s degree in chemistry/biochemistry/related

Master’s degree

PhD

Job description

AbbVie seeks a seasoned regulatory leader to drive global CMC dossier preparation for novel synthetic molecules, coordinating cross-functional teams of subject matter experts to ensure high-quality regulatory submissions. The role focuses on aligning CMC submission strategy with clinical and regulatory development goals, while implementing efficient processes and maintaining up-to-date control strategies.

The incumbent will guide dossier authors, refine submission templates, and mentor team