Hiroto HiguchiSenior Advisor, 
Regulatory Affairs

Hiroto Higuchi Senior Advisor, Regulatory Affairs

Hiroto Higuchi has over 40 years of experience in the Japanese pharmaceutical industry.
Mr. Higuchi started his career from veterinary drug development and dedicated himself to the job for 7 years in Upjohn Japan, Bayer Japan and Bristol-Myers Squibb.

Mr. Higuchi moved then from veterinary drug development group to regulatory affairs group in Bristol-Myers Squibb and continued working in regulatory affairs for over 33 years.

Mr. Higuchi worked at Wyeth Japan as the head of regulatory affairs and achieved several approvals of new drugs in oncology, vaccine, hemophilia in pediatric and rheumatoid arthritis.

After merger with Pfizer,Mr. Higuchi moved to global regulatory affairs as the regulatory head of Asian region to develop new drugs in Asian region. Notably, Mr. Higuchi worked also at AstraZeneca as the head of non-clinical department (CMC/pre-clinical and regulatory) and achieved approval of IRESSA for NSCLC in Japan.

Until 2016, Mr. Higuchi was the head of regulatory department in Novartis Oncology Japan to contribute developing innovative cancer drugs in Japan, collaborating with global colleagues. Before Novartis Oncology,

Mr. Higuchi joined JCRO from 2016-202o as Senior Advisor of regulatory affairs and rejoined in January 2023. In between, he also served as Board Director and head of Japan regulatory affairs unit in GSK from 2020-2022.

Mr. Higuchi has accumulated skills, knowledge, expertise, and communication channels for development of innovative drugs through his job to date making him well positioned to supporting biopharma companies to accelerate simultaneous global development of innovative drugs in the oncology area, particularly for rare and pediatric diseases.


  • Elaborate on Japanese regulations, regulatory system and its process.
  • Establish regulatory strategy and build tactics of Japanese development in line with clients’ global plan.
  • Facilitate communication with PMDA to assure smooth PMDA Consultation and Clinical Trial Notification submission.
  • Utilize regulatory knowledge and expertise to accelerate clinical trials in Japan.