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Provide strategic regulatory and scientific support on pre-clinical and clinical development plans and work with both Regulatory Affairs - New Products and Regulatory Affairs...
Responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence function. The head of GRO and GRA Excellence will represent the department...
Lead the Design Control process for drug/device combination products and create phase-based Design Control documents (DDP, URS, DRS, DV&V, DTx, DHF, etc.). Determine the...
Monitor and analyze the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which the clients' products are regulated...
This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...