Koen Crombez
About Koen Crombez
Koen Crombez is the Director of Global Regulatory Science EU Strategy Oncology at Bristol-Myers Squibb, with over 15 years of experience in regulatory affairs within the pharmaceutical industry.
Current Role at Bristol-Myers Squibb
Koen Crombez currently serves as the Director of Global Regulatory Science EU Strategy Oncology at Bristol-Myers Squibb in the Brussels Area, Belgium. In this role, he is responsible for leading the regulatory strategy for oncology within the European Union. His work involves ensuring compliance with regulatory requirements and contributing to the development and implementation of regulatory policies and procedures.
Previous Experience at Merck
Prior to his current role, Koen Crombez held multiple positions at Merck. He served as the Executive Director, Therapeutic Area Lead Regulatory Affairs Europe from 2016 to 2018. From 2013 to 2016, he was the Director of Regulatory Affairs Europe based in Kenilworth, New Jersey, United States. He also held the roles of Associate Director Regulatory Affairs Europe and Senior Manager Regulatory Affairs Europe, both based in the Brussels Area, Belgium.
Academic Background
Koen Crombez earned a PhD in Medical Sciences from KU Leuven, where he studied from 2001 to 2005. Prior to that, he completed a Master in Biological Sciences at KU Leuven from 1995 to 1999. His academic background provides a solid foundation for his extensive career in regulatory affairs within the pharmaceutical industry.
Experience in Regulatory Affairs
Koen Crombez has over 15 years of experience in regulatory affairs within the pharmaceutical industry. He has a strong background in oncology regulatory science within the European Union. Throughout his career, he played a key role in the regulatory approval of multiple oncology drugs during his tenure at Merck. His extensive experience includes leading regulatory strategy for major pharmaceutical companies and successfully navigating complex regulatory environments in Europe.
Expertise in European Regulatory Framework
Koen Crombez possesses a deep understanding of the European Medicines Agency (EMA) regulatory framework. He has been involved in cross-functional teams to ensure compliance with regulatory requirements. His expertise extends to the development and implementation of regulatory policies and procedures, notably at Bristol-Myers Squibb. Crombez's comprehensive knowledge of EU regulatory science has been instrumental in his successful career in the pharmaceutical industry.