Kazumi Sawaguchi

Upon earning her Ph.D. in Pharmacokinetics, Dr. Sawaguchi worked in project management for new drug development at both domestic and foreign pharmaceutical companies, participating in a wide range of development work from the launch of clinical trials to the approval stage. Thereafter, she worked for foreign pharmaceutical companies and CROs in development and regulatory affairs, and has extensive experience in PMDA consultation and application for and acquisition of approval. Dr. Sawaguchi has served as Vice president of Regulatory Affairs, Intelligence/Policy, and Quality Assurance Unit at Konica Minolta Precision Medicine Japan, Head of Regulatory Affairs at PAREXEL Consulting Japan, Head of Regulatory Affairs at Mylan Seiyaku/Mylan EPD, Senior Manager, Project Management Department at Janssen Pharmaceutical, Senior Manager, Development Strategy Office at Eisai, Senior Manager, Development Department at Daiichi Sankyo, and Executive Director at Kansai Pharmaceutical Association.