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#25: Precedent: A Driver of Regulatory Strategy


  • Kimberly  Belsky, MS

    Kimberly Belsky, MS

    • Senior Director, Regulatory Affairs, Regulatory Policy and Intelligence
    • Mallinckrodt Pharmaceuticals, United States

    Kimberly (Kim) Belsky is a Sr. Director of Regulatory Intelligence at Mallinckrodt Pharmaceuticals. Prior to that, Kim was an Executive Director at OneSource Regulatory (OSR) and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals. In latter role, Kim was responsible for a diverse portfolio that included Rx drug (brand and generic) OTCs/Nutritionals/Cosmetics, and devices. Kim has 26 years of pharma experience, with 16 in regulatory affairs.

  • Robert  Kester, MS

    Robert Kester, MS

    • Director, Global Regulatory Affairs
    • Merck & Co., Inc., United States

    Robert Kester is a Director, Global Regulatory Liaison, in the Oncology & IVD group at Merck & Co. Inc. He has been at Merck for more than five years and began as a Regulatory Liaison focused on developing Rest of World regulatory strategies for cardiovascular and oncology products. In 2016, Robert transitioned to his current role supporting the global development of oncology products and for the past two years has also been the Chief of Staff to the VP of the Global Regulatory Affairs, Oncology & IVD group. Prior to joining Merck, Robert spent 15 years committed to his work at Roche as a Discovery Chemist. He worked in multiple therapy areas including Metabolic Diseases, on the Glucokinase Activator program, and Oncology.

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