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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...
Create and Review regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals; Track status and progress of regulatory...
As an (Associate) Director, Global Regulatory Affairs Project Lead you will join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for...