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Kate Simon

Senior Director, Global Regulatory Strategy IVD

Kate Simon, Ph.D., is an accomplished professional in global regulatory strategy, currently serving as Senior Director for Global Regulatory Strategy in In Vitro Diagnostics at Bayer since July 2023. Prior experience includes Director of Global Regulatory Affairs for Precision Medicine at GSK from November 2019 to June 2023 and Senior Manager of Regulatory Affairs at QIAGEN from June 2018 to October 2019. Kate also held the position of Senior Consultant for In Vitro Diagnostic Devices at Biologics Consulting Group between January 2015 and May 2018, following a decade at the FDA's Center for Devices and Radiological Health where roles included Master Reviewer and Reviewer. Kate Simon earned a Doctor of Philosophy (Ph.D.) from the University of Virginia between 1995 and 2000, and a Bachelor’s degree from the University of New Hampshire, Durham, NH, from 1990 to 1994.

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