Associate Director, CMC Dossier Strategy and Leadership

AbbVie · North Chicago

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Company
AbbVie
Location
North Chicago
Employment type
Full-time
Posted
September 29, 2026

About this job

Leads global regulatory dossier preparation activities for novel synthetic molecules by coordinating cross-functional teams of subject matter experts, from internal and external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Implement well-defined, efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory development strategy and provides drug development experience and advice to the CMC team.…

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