Project Description

Product Development Champion

Jamie’s 39-year professional path in the pharma industry started with The Upjohn Company and has taken him from the research laboratory to clinical development and eventually to regulatory affairs.  He enjoys being close to the action and being involved in carrying the ball across the goal line (FDA Approval!).  Following his stint with Upjohn/Pharmacia/Pfizer, he joined Perrigo where his focus was on developing and implementing regulatory strategies for 505(b)(2) NDAs and ANDAs for prescription and over-the-counter products, as Associate Director of Regulatory Affairs. He enjoys the “soup-to-nuts” aspect of regulatory science, being a communicator and being able to tell the whole story. The sense of accomplishment in filing a new IND for a new molecular entity or in getting approval of a new indication for an approved drug, motivates him day-to-day. His specialty includes product development planning, regulatory submission strategy and post-approval life-cycle maintenance for multiple NDA and ANDA drug products.  He has extensive background and experience in a broad range of regulatory development stages, from discovery to pre-IND to life cycle product management.    He is passionate to apply his broad knowledge and experiences to meet new drug development challenges for clients.

Jamie is a true “Michigander” (or is it “Michiganian”? The debate continues), having lived primarily in Michigan his entire life.  In his free time, Jamie can be found captaining the family pontoon boat on a sunny summer afternoon or just enjoying time on the lake with a Michigan craft beer in his hand.  He is the quintessential “tinkerer” (having inherited that trait from his father) and enjoys dissecting and discovering how things work.  He also spends his time woodworking, golfing or providing handyman services (pro-bono, of course) to his four grown children and their families.