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In line with defined product responsibilities, utilize regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country...
Manages audit planning, assignments, support, and reporting of research and development submissions, pre-clinical, Clinical Research (GCP), Pharmacovigilance (PV), Laboratory (GLP)...
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...
Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical...