Makoto Nagaoka, PhD
Senior Director, Regulatory Affairs & Head of Regulatory Affairs, Japan
Makoto Nagaoka, PhD is a Senior Director and Head of Regulatory Affairs Japan at Fortrea, leading Regulatory Strategy Consulting and regulatory submissions in Japan. He oversees regulatory agency interactions, global RA/IRB/EC submissions and serves as a strategic regulatory advisor to support client‑focused development and execution in Japan.
Makoto brings more than 20 years of experience across nonclinical regulatory science, clinical science, regulatory strategy and regulatory intelligence, covering therapeutic areas including oncology, neurology, ophthalmology, dermatology and inflammation. Prior to joining Fortrea, he held senior leadership roles in global and Japan regulatory affairs across major pharmaceutical and biotech organizations, leading PMDA and MHLW interactions through approval and shaping regional regulatory policy and development strategies in APAC and globally.
He holds a BS, MSc and PhD in Pharmaceutical Sciences from Kyoto University and is a licensed pharmacist in Japan.