Rie Taguchi joined ELIQUENT Japan (formerly IDEC) in 2022, following a career with two major specialities in quality areas, such as CMC and GMP.

In CMC area, she has more than 15 years of experience in chemical and biological product development as a CMC lead at multinational pharmaceutical companies. She has extensive CMC knowledge and experience from pre-IND to post-approval life cycle management. Her expertise is not only in the preparation of J-NDA CTD documents but also in J-NDA-related works (e.g., Japanese Drug Master File registration, Foreign Manufacturing site Accreditation, supporting every manufacturing site for GMP inspection). She has good communication and consultative skills and obtains the desired outcome at the consultation with Japanese Health Authorities. In GMP, she has managed the GMP inspection since 2005 as a member of the R&D division of Market Authorization Holder. She communicated with all relevant manufacturing sites and compiled the documents to respond to the PMDA queries.

After transferring to the manufacturing site of a foreign capital pharmaceutical company, she led the GMP inspection task force team and managed the entire site audit. Her broad knowledge of CMC and GMP contributed to the smooth approval.