Unknown Company

Senior CMC Regulatory Affairs Lead — First-Pass Strategy

waltham, ma • Posted 1 months ago
Onsite Full Time Management & Operations

AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions across INDs/CTAs and amendments. You will partner with R&D, Operations and product teams to ensure timely, compliant filings and first-pass approvals, while guiding cross-functional teams through evolving regulatory landscapes.

The role emphasizes strategic liaison with agencies like the FDA, strong communication skills, and leadership in a matrix environment.

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Senior CMC Regulatory Affairs Lead — First-Pass Strategy in waltham at Unknown Company

This position is listed as full time and onsite.

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