As Japan Regulatory Affaires of ELIQUENT Life Sciences, Motoyuki Yoshida is responsible for the preparation of the CDISC compliant electronic data and other Japanese regulatory documents for all the ELIQUENT product development services and the electronic submission (eSubmission) of these J-NDA packages to the regulatory authorities using the PMDA Gateway system.

Motoyuki has over 15 years of global drug development experience in senior regulatory affairs roles in pharmaceutical companies.

At ELIQUENT Japan, he participates in negotiations and communications with Japanese regulatory authorities to gain regulatory acceptance of non-CDISC compliant clinical trial data, such as legacy or missing data, and leads the preparation of the appropriate data/documentation to achieve eSubmission of the J-NDA package on schedule. He is also responsible for leading the compilation of the eCTD to ensure that it complies with the latest regulatory guidance.

He has a wealth of experience in managing the import/export of Investigational Products (IPs), including the preparation of the IP label and GCP document to conduct the clinical trial in Japan as the GMP/GCP document record keeper.

Furthermore, he has experience in coordinating the preparation of submission documents for J-NDA filing, including experience as a senior manager in the regulatory affairs department of a global CRO, where he established the Japanese branch and led the negotiations with the Japanese regulatory authorities and responses to the GCP compliance review (Written Inspection).