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Kim Quaintance-Lunn

Vice President and Head, Regulatory Policy, North American Regulatory Affairs, Bayer
DIA Inspire Award Winner

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When did you realize you wanted to work as a regulatory professional?

From birth! :-) But seriously, I had been working in the lab doing research and realized that I wanted to move in a new career direction. Translating the data I was generating into access for patients via regulatory approval held a definite appeal, and the rest, as they say, is history.

In your opinion, what is the greatest challenge in your field?

The greatest challenge in my view is the lack of harmonization among global health authorities. I will moderate that statement by saying that we should not harmonize for the sake of harmonization. We should harmonize to the best practice.

What is the first book you remember reading?

First book? Probably something by Dr. Seuss. But one of the first novels I remember reading, and falling in love with, is To Kill a Mockingbird by Harper Lee. I’m very excited to be able to see the adaptation of the novel on Broadway this summer!

What advice would you give your younger self about to enter the “real world?”

First, work hard and do your best, no matter what the task. Your work ethic reflects on who you are; I tend to hire for attitude and train for skills. Second, be open to opportunities. It may not be “the job” you want now, but it could be the stepping stone towards a future opportunity! And last, but perhaps most important, find your passion.

How has DIA helped you?

DIA offers so many opportunities, and I believe I have taken, and continue to take, advantage of all of them. There are the educational offerings, where you can increase your knowledge. DIA events offer the chance to network with other professionals and build relationships… I have met many people through DIA that I now consider not only professional allies, but also close friends. Finally, DIA has given me various experiences that have helped me grow as a professional. I am grateful for all the opportunities I have had over the years, and I am proud to be associated with DIA!

Kim Quaintance-Lunn serves as Vice President and Head, Regulatory Policy, North American Regulatory Affairs, at Bayer. Kim joined Bayer in February 2014 to establish and lead the US regulatory policy function for the organization. She works with colleagues to analyze regulatory policy and advocate for changes in the regulatory environment, serves on global and US Regulatory Leadership teams, and assists in the development of regulatory strategies. Kim previously served as the Senior Director, Global Regulatory Policy and Intelligence at Eisai and as the Associate Director for Regulatory Affairs in CDER’s Office of New Drugs. Kim began her career in the pharmaceutical industry working as a research scientist in drug metabolism at Pfizer.

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