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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...
Core activities will include conducting HTA (NICE in particular) compliant SLRs, developing and running literature database searches, data evaluation and extraction, report...
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...