Meike Vanhooren
Senior Director @Pfizer
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WORK HISTORY
Senior Director @Pfizer
EDUCATION
Wolfgang-Borchert-Gymnasium, Halstenbek
Abitur
Universität Hamburg / University of Hamburg
Ph.D. & Master
ABOUT MEIKE VANHOOREN
Dr Vanhooren has more than 25 years of experience in the pharmaceutical industry covering regulatory, manufacturing and quality areas. She is based in Germany and has global responsibility for Chemistry Manufacturing Control (CMC). Her portfolio touches the complete product life cycle, from IND /IMPDs for First-in-Human clinical studies, NDA / MAA applications through post approval lifecycle maintenance. With her international team she is accountable for: • effectively engaging regulatory authorities and ensuring legal obligations to maintain conformance and compliance are met; • developing regulatory strategies globally and providing regulatory clarity for scientists in research & development and manufacturing divisions.Dr Vanhooren has extensive experience in drug development of accelerated programs as well as programs with novel technologies such as continuous manufacturing processes including successful MAA / NDA approvals. She has been responsible for executing CMC strategies for manufacturing site changes and successfully completed more than 900 transfers impacting more than licenses globally. Dr Vanhooren is engaged in discussions on ICH Q12 Lifecycle Management and ICH Q13 Continuous Manufacturing.Dr Vanhooren earned her Ph.D. in organic synthesis of carbohydrate structures at the University of Hamburg, Germany.
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