Regulatory CMC Manager (f/m/x)
- Vienna
The Regulatory CMC Manager will be in charge of directing and managing Regulatory Affairs activities for developing global CMC strategies across product life cycles with a clear focus on providing collaborative support for execution of global strategies for the Plasma-Derived Therapies portfolio. * Proactively contribute to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant Company R&D, PDT BU R&D and Commercial functions to obtain, maintain and extend Company PDT BU product registrations in the United States, Japan, the European Union, Canada and emerging markets * Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies * Develop global CMC regulatory strategy for one or more investigational and marketed products
The Regulatory CMC Manager will be in charge of directing and managing Regulatory Affairs activities for developing global CMC strategies across product life cycles with a clear focus on providing collaborative support for execution of global strategies for the Plasma-Derived Therapies portfolio. * Proactively contribute to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant Company R&D, PDT BU R&D and Commercial functions to obtain, maintain and extend Company PDT BU product registrations in the United States, Japan, the European Union, Canada and emerging markets * Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies * Develop global CMC regulatory strategy for one or more investigational and marketed products
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