Global CMC Regulatory Lead — Dossier Strategy

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)

Long-term incentive programs

Job summary

AbbVie in North Chicago, IL seeks a Senior leader to drive global regulatory CMC dossier preparation for novel molecules. You will coordinate cross-functional teams to deliver high-quality CMC submission documents aligned with development strategy and global regulatory requirements.

Responsibilities include leading the CMC team, developing submission templates, mentoring authors, and influencing regulatory guidance while ensuring timely responses to authorities and continuous process

Qualifications

• Extensive experience leading CMC regulatory submissions through late-stage development and marketing applications.
• Demonstrated ability to coordinate cross-functional teams and manage timelines under pressure.
• Proven scientific writing skills with INDs or marketing applications.
• Strong understanding of global regulatory requirements for pharmaceutical development.

Responsibilities

• Author and coordinate global CMC submission documentation across development phases.
• Lead the CMC team to ensure compliance with regulatory requirements.
• Develop and maintain submission templates and processes for CMC regulatory documents.
• Mentor and develop dossier authors, fostering high-performing teams.

Skills

CMC Leadership

Regulatory Submissions

Cross-functional Leadership

Strategic Thinking

Scientific Writing

Education

PhD in Chemistry/Pharmaceutical Sciences

MS in Chemistry/Pharmacology

Tools

Document Management Systems

Regulatory Submission Tools

Job description

AbbVie in North Chicago, IL seeks a Senior leader to drive global regulatory CMC dossier preparation for novel molecules. You will coordinate cross-functional teams to deliver high-quality CMC submission documents aligned with development strategy and global regulatory requirements.

Responsibilities include leading the CMC team, developing submission templates, mentoring authors, and influencing regulatory guidance while ensuring timely responses to authorities and continuous process