Mike_Day

Director Regulatory Science, Co-Head Complex Biologics

As a Director Regulatory Science and Co-Head Complex Biologics at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced therapies.

Mike has over 20 years of experience in the pharmaceutical/biopharmaceutical industry and consulting services, having worked on the review, preparation, and maintenance of numerous regulatory documents and submissions, including INDs, ANDAs, BLAs and NDAs.

Prior to joining VCLS, Mike was the Managing Director of CMC/Global Regulatory Affairs at Cardinal Health Regulatory Sciences. Whilst there, he was responsible for providing comprehensive regulatory and CMC global strategy to clients at various stages of their product development. This covered advising on drug formulation, as well as device and combination product development. He was also responsible for providing leadership and the development of regulatory/scientific staff. 

Over this time, Mike has led and attended a large number of meetings and interactions with FDA, including information requests, pre-IND, end-of-phase 2, pre-NDA, and Type C/Scientific advice. This has involved close collaboration with a number of FDA divisions including: the Division of Oncology Products, the Division of Neurology Products, the Office of Tissues and Advanced Therapeutics, the Office of Generic Drugs, and the Office of Combination Products.

 

He has a thorough comprehension of modern techniques of analytical chemistry including the development and validation of methods, installation, operation, and performance qualifications of instrumentation.  Additionally, Mike has significant experience in performing cGMP compliance audits.

 

Mike received his PhD in Pharmaceutical Sciences and Chemistry from the University of Missouri-Kansas City. He also currently serves as adjunct faculty for University of Missouri-Kansas City, School of Pharmacy and is the Vice-President of the Pharmaceutical Technical Exchange Association.

 

Mike is based in VCLS offices in Cambridge, MA, USA.

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