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Repeat Solutions Circle
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Michael Day, PhD

Senior Director of Regulatory Strategy
Cencora PharmaLex

Michael Day, PhD is Senior Director of Regulatory Strategy at PharmaLex–Cencora, where he leads U.S. regulatory and CMC strategy for complex biologics, advanced therapies, and small molecules. He brings over 25 years of experience in U.S. regulatory affairs, specializing in IND/BLA submissions, development-stage strategy, and lifecycle management.

Dr. Day advises global biopharma clients on regulatory risk mitigation, FDA engagement, and CMC readiness, with a particular focus on cell and gene therapies where manufacturing and quality challenges increasingly drive approval outcomes. He has extensive expertise in preparing regulatory briefing packages, managing FDA interactions, and aligning CMC development plans with evolving regulatory expectations.

At PharmaLex–Cencora, Dr. Day also contributes to cross-functional initiatives that integrate regulatory, quality, and manufacturing perspectives to help sponsors anticipate FDA concerns and achieve first-cycle approvals.

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