Vice President, CMC Regulatory and QA
Mr. Nishiyama is responsible for HUYABIO’s CMC Regulatory and Quality Assurance in Japan. With over 40 years experience, he has deep expertise in regulatory and project management, focusing on CMC regulatory development and product quality management. Yoshiki has a broad regulatory background in new product development, implementation of requirements for regulatory submissions, and regulatory affairs maintenance of post-marketed products. He has served globally, liaising with Asian regulatory agencies for regional clinical trials initiation in North East Asia at GlaxoSmithKline, Marion Merrell Dow, Eli Lilly, and Merck Serono Japan. Mr. Nishiyama received a BSc in Engineering from Gunma University. He is a member of the Pharmaceutical Society of Japan and the Society for Regulatory Science of Medical Products.