Associate Director, CMC Dossier Strategy and Leadership
AbbVie · North Chicago, IL
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Role summary
Associate Director role leading global regulatory dossier preparation for synthetic drug molecules at AbbVie. Coordinates cross-functional CMC teams to ensure high-quality, compliant submission documents aligned with clinical development strategy while managing regulatory requirements and process improvements.
What they're looking for
- Bachelor's degree with 12 years CMC experience, or Master's with 10 years, or PhD with 7 years
- 2+ years leading technical professional teams
- Interdisciplinary CMC functional experience across chemistry, analytics, formulation
- Late-stage development and laboratory-based drug substance/product manufacturing background
- Demonstrated scientific writing expertise in INDs and marketing applications
- Strong written and verbal communication with regulatory knowledge
What you'll be doing
- Author and coordinate CMC submission documentation across clinical development phases, emphasizing later-stage and marketing applications
- Lead global cross-functional CMC team in regulatory document completion and respond to regulatory authority questions
- Develop standardized processes, templates, and project planning frameworks for CMC submission documentation
- Collaborate on control strategy development and data package planning throughout drug development
- Mentor dossier authors, identify process improvements, and facilitate high-performing team establishment
Privacy & handoff
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