Hirofumi Suzuki, PhD

Bayer Yakuhin Ltd.
Regulatory Affairs CH Japan, Manager
Hirofumi Suzuki is Regulatory Affairs CH Japan Manager at Bayer Yakuhin based in Osaka, Japan. He is responsible for project management of implementation of new products in Product Supply Japan. He has over 30 years of experience in CMC development, managing Regulatory activities, Pharmaceutical Development, Investigational Products Supply and Quality Assurance. He served as Head of CMC at Bayer Yakuhin/Nihon Schering and held multiple positions in CMC area at Nihon Organon and Kanebo Japan. He worked at Northeastern University from 1995 till 1996 as Visiting Scientist. He actively engaged as Head of EFPIA Japan Quality Group from 2014 to 2016 and Head of Pharmaceutical Experts Group of Japan Pharmaceutical Manufacturers Association (JPMA) from 2016 to 2018. After joining ISPE in 2008, he became Japan IP-COP leader, Director of ISPE Japan Board from 2010 and Chair of ISPE Japan from 2017 to 2019. He is currently Director of ISPE International Board as well as ISPE Foundation Board. He has a PhD in pharmaceutical sciences from Okayama University and MBA from NUCB.