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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...
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...
Design, construct, overexpress, and perform screening/selection assays for recombinant proteins; Participate in protein expression optimization and purification at different...
As a key member of the Regulatory & Medical Affairs department, you will provide strategic direction and leadership across a broad range of medical affairs activities, ensuring the...