Ryo Kondo, M. Pharm, Leader, Regulatory CMC, Research & Development, AstraZeneca
Ryo Kondo is Leader in the Regulatory CMC Department in Research & Development (R&D) at AstraZeneca, located in Japan. In his current role, he works on drug development programs across all phases of clinical development, post-approval and life-cycle of products. He also delivers CMC regulatory strategy as well as operational and executional expertise for drug development projects from Phase I through to launch in Japanese market for both small molecules and biologics including COVID-19 products and vaccines. During the pandemic, he had a significant contribution to gain approval of COVID-19 vaccine in Japan. He oversees CMC documentation packages (CMC-related IND documents, Quality of the Common Technical Document and CMC sections of briefing documents) for regulatory submissions including initial submission to the authorities, and preparation of responses to inquiries from the authorities. He has over 25 years of experience in Regulatory CMC. He is a licensed pharmacist and holds a Master’s degree in Pharmaceutical Sciences from Setsunan University in Osaka, Japan. From 2011 to 2022, he was a member of Quality & Technology Committee in Japan Pharmaceutical Manufacturers Association (JPMA). Since 2022, he has been a member of Technical Research Committee in Kansai Pharmaceutical Industries Association (KPIA).