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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...
Develop and maintain excellent thought leader relationships in the field of rare disease specifically Fabry Disease, Pompe Disease and Batten Disease; Lead on medical initiatives...