Rieko Shimazu

Regulatory Affairs Practice – Japan

BACKGROUND

FOCUS AREAS

More than 30 years of experience in clinical development.

Medical Writing

Rieko Shimazu is a clinical medical writer at ELIQUENT Japan. She contributes to developing drugs in Japan by preparing regulatory documents.

Rieko prepares regulatory dossier for J-NDA, PMDA Consultation Meetings, J-Orphan Drug Designation, etc. and contributes to obtaining approval from PMDA (Japanese Health Authorities) and introducing the drugs into the Japanese market.

Rieko has more than 30 years of clinical development experience, including work as a clinical research associate (CRA), regulatory affairs (RA), medical writer (MW), medical affairs (MA), and clinical scientist in international and Japanese pharmaceutical companies such as AbbVie, Synergen, AstraZeneca, and Sumitomo Pharma.