Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.
OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.
Provide CMC regulatory expertise for investigational and marketed products to project teams. Establish CMC regulatory strategies for investigational and marketed products. Ensure Otsuka’s products are developed in compliance with global regulatory requirements and guidances primarily US and secondarily EU for smooth and timely approvals. Ensure Otsuka’s marketed products are in compliance with global regulatory and guidance requirements primarily US and secondarily EU.
Additional Responsibilities Include:
Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. preferably majoring in Pharmaceutics or Industrial Pharmacy and minor in Medicinal Chemistry or vice-versa