Amalia Himaya
Senior Regulatory Project Manager
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About
Regulatory affairs professional with FDA experience managing multi-disciplinary review teams and providing timely regulatory input to facilitate sound decision-making. Strong knowledge of US laws, regulations, and policies regarding the regulation of drug and biological products. Specialized expertise in
FDA inspections, safety, and policy development.
Experience
Regulatory affairs professional with FDA experience managing multi-disciplinary review teams and providing timely regulatory input to facilitate sound decision-making. Strong knowledge of US laws, regulations, and policies regarding the regulation of drug and biological products. Specialized expertise in
FDA inspections, safety, and policy development.
