US-MA, Lead, Regulatory Affairs CMC, Plasma-Derived Therapies Business Unit (Director level) SR0046237-MZ
The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients and health care providers expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. The Head, Global Regulatory Affairs Strategy, Plasma-Derived Therapies Business Unit will have the ability to create and define the future vision and operating model for the team. There will be two main drivers of innovation in the newly-formed PDT R&D group:
Under limited supervision, the Lead, Regulatory Affairs CMC/Device, Plasma-Derived Therapies Business Unit (GRA PDT BU) is responsible for developing, coordinating and implementing global CMC/Device regulatory strategies and submission planning for the PDT development and lifecycle drug product portfolio. Specifically, the Lead, Regulatory Affairs CMC/Device is responsible for providing proactive leadership and strategic guidance to the assigned team of Regulatory Affairs CMC contractors by defining and optimizing global regulatory strategies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the United States and international markets. The role will serve as the liaison to, and oversees the regulatory affairs relationship with, internal CMC stakeholders and US & International Health Authorities for CMC/Device issues pertaining to the Lead's assigned team.
70%: Strategic Leadership & External Interactions
15%: PDT BU R&D Leadership
15%: Culture and People Leadership
Education and Experience Requirements
Other Job Requirements
~15-20% national and international travel anticipated
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