Hemal Shah

Senior Scientist - Regulatory Affairs CMC at Merck

Hemal Shah is a Senior Scientist in Regulatory Affairs CMC at Merck since May 2020. Previously, Shah served as a Project Leader/Senior Scientist at Endo International plc, managing multiple ANDA projects and contributing to regulatory submissions through comprehensive documentation. Earlier experiences include roles as a Research Scientist-III at Endo International, where complex analytical methods for various dosage forms were developed, and as a Scientist at Teva Pharmaceuticals, focusing on transdermal patch development. With a robust background in analytical testing and method development across multiple organizations, Shah began the professional journey as a Validation Engineer and a Quality Assurance Specialist. Hemal Shah holds a Master of Science in Pharmaceutical Manufacturing Practice from Stevens Institute of Technology and a Bachelor of Science in Pharmacy from Rajiv Gandhi University of Health Sciences.

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