Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.
The Director of Regulatory Affairs provides strategic global regulatory guidance to cross-functional project teams responsible for product development. The successful candidate has a proven track record in the development of drugs, biologics/vaccines, and also in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional project teams to execute the agreed-upon strategies; supports departmental activities with regards to clinical trial conduct and regulatory submissions.
Reporting to the Senior Director of Regulatory Affairs and CMC, the Director will:
Ph.D. or Pharm. D. or equivalent experience in a scientific discipline or equivalent will be preferred. Bachelors or Master’s Degree will be considered with relevant experience in Regulatory Affairs. Regulatory Affairs Certification is favorable.