Global CMC Dossier Strategy Lead

AbbVie Inc.; Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie Inc. is seeking a seasoned professional to lead global CMC submission activities for biologics, coordinating cross-functional teams to ensure high-quality regulatory documents.

The role emphasizes alignment with clinical development strategy and timely responses to authorities. Responsibilities include mentoring dossier authors, developing submission templates, and mitigating regulatory risks while maintaining strong external collaborations and internal leadership.

Qualifications

• Interdisciplinary experience required; biologics experience strongly preferred.
• Excellent scientific writing skills including INDs/marketing applications; regulatory knowledge.
• Strong communication, written and verbal; summarize and communicate findings efficiently.
• Decision-making based on scientific data; manage multiple projects with urgency.
• Negotiation, influencing others, and leadership demonstrated.

Responsibilities

• Author and coordinate submission documentation for all phases of clinical development of biologics, with emphasis on later phase programs and marketing applications.
• Lead the global cross-functional CMC Team in completion of global regulatory submission documents; ensure global regulatory requirements are met.
• Develop relationships with external partners and internal stakeholders; demonstrate negotiating and leadership skills.
• Manage completion of CMC regulatory submission documentation for multiple projects of moderate complexity using a matrix management approach.
• Interface with CMC Regulatory to plan, review and approve CMC submission sections; develop templates with CMC Regulatory and Process R&D.
• Identify submission-related risks and develop mitigation strategies with CMC Regulatory.
• Coordinate document authoring and reviews with Process R&D Ops S&T, preclinical safety, PK, QA; ensure consistency across projects.
• Lead cross-functional initiatives to streamline submission processes; develop high-performing teams; mentor dossier authors where needed.

Skills

Biologics experience

Scientific writing

Regulatory submission

Leadership

Cross-functional collaboration

Education

Bachelors Degree

Masters Degree

PhD Degree

Job description

AbbVie Inc. is seeking a seasoned professional to lead global CMC submission activities for biologics, coordinating cross-functional teams to ensure high-quality regulatory documents.

The role emphasizes alignment with clinical development strategy and timely responses to authorities. Responsibilities include mentoring dossier authors, developing submission templates, and mitigating regulatory risks while maintaining strong external collaborations and internal leadership.