Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, 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 Senior Director, Regulatory Affairs provides strategic regulatory guidance to cross-functional project teams responsible for product development and post marketing commitments. He/she defines and implements global regulatory strategies, translating regulatory requirements into practical, workable plans in order to facilitate timely drug development and registration. The Senior Director, Regulatory Affairs works with cross-functional project teams to execute the agreed-upon strategies; interacts with regulatory agencies to negotiate agreements; coordinates the planning and conduct of regulatory agency meetings; and supports departmental activities with regards to clinical trial conduct and regulatory submissions.