Hirofumi Suzuki has a PhD in pharmaceutical sciences from Okayama University and MBA from NUCB. He has been Senior Regulatory CMC Adviser since February 01, 2019 of Bayer Yakuhin Ltd. Japan. He served as Head of CMC of Bayer Yakuhin since 2007 until 2019. In this position he managed Regulatory activities, Pharmaceutical Development, Investigational Products Supply and Quality Assurance. He served as Head of CMC Development Department of Nihon Schering K.K. Japan since 2004 until 2007. Prior to Schering, he held multiple positions in CMC area at Nihon Organon and Kanebo Japan. While at Kanebo, he worked at Northeastern University since 1995 till 1996 as Visiting Scientist. During more than 30 years of experience in CMC development, manufacturing and quality, he served as Head of Pharmaceutical Experts Group of Japan Pharmaceutical Manufacturers Association since 2016 till 2018 and Chair of ISPE Japan since 2017 till 2019.