Senior Manager, Global Regulatory Device Labeling Strategy Lead
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About The Position
The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma derived therapies for patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager) Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling. This role is responsible for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Device Development, Pharmacovigilance, Legal, Scientific, and Commercial, to ensure successful development and maintenance of Instruction for Use (IFU) documents and Device Packaging Labeling content in line with US and EU standards and guidelines.
