John Huber, Ph.D.: Head of Global Regulatory Affairs | Takeda Oncology
Profile Section
John Huber, Ph.D.
Biography
John Huber, Ph.D., is Head of Global Regulatory Affairs for Oncology and a member of the Oncology Leadership Team. In this role, he is responsible for overseeing all aspects of regulatory strategy for products in development and on the market, spearheading the execution of progressive regulatory strategies that facilitate the development and commercialization of Takeda’s oncology assets. John brings over 15 years of industry experience to the role, spanning both research and development, including well over a decade in regulatory affairs.
John joined Takeda in 2022 as Executive Director, Global Portfolio Lead in the oncology regulatory affairs team where he led a team responsible for a sizable portion of the Takeda Oncology pipeline, including all pre-clinical development assets and a number of clinical stage assets. In this position, he also led regulatory affairs efforts in oncology business development.
Prior to joining Takeda, John worked at Regeneron where he was Senior Director, Regulatory Affairs and was responsible for leading the regulatory strategy for the respiratory portfolio, as well as additional programs in other disease areas. During his time at Regeneron, he led multiple major regulatory submissions and reviews including in the US, EU, and Japan. Before this, John spent 6 years at Bristol-Myers Squibb working in the oncology therapeutic area as a global regulatory lead making significant contributions across a large number of programs spanning all stages of development and multiple modalities. John began his industry career at Boehringer-Ingelheim Pharmaceuticals as a lab leader responsible for small molecule drug discovery efforts for programs across the immunology, cardiovascular, and chronic kidney disease areas.
John holds a Ph.D. from Columbia University in synthetic organic chemistry and a BA in chemistry with a minor in sociology from Swarthmore College. John is based in Cambridge, MA.