Lead, Regulatory Affairs CMC and/or Device, Plasma-Derived Therapies Business Unit
- Wien
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 for all programs under the Lead's oversight. Specifically, the Lead, Regulatory Affairs CMC/Device is responsible for providing proactive leadership and strategic guidance to the assigned team 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, US and International Health Authorities for CMC/Device issues pertaining to the Lead's assigned team.
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 for all programs under the Lead's oversight. Specifically, the Lead, Regulatory Affairs CMC/Device is responsible for providing proactive leadership and strategic guidance to the assigned team 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, US and International Health Authorities for CMC/Device issues pertaining to the Lead's assigned team.
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