Winner. Scientist of the Year 2024

Gaurang Mahendrakumar Bhavsar

Academic title, degree: Master of Science in Industrial Pharmacy
Fields of science: Pharmaceutical Industry
Research interest: Regulatory Compliance, Regulatory Requirements, DSCSA, Validation, Nitrosamine Impurities, Microdialysis, Anti-fungal activity, Product Development, Patient safety
Career Development: Senior
Organization: Micro Labs USA, Inc.
Position: Associate Director - Regulatory Affairs
City: Somerset, New Jersey
Country: USA

Gaurang Bhavsar, Master of Science in Industrial Pharmacy, is a seasoned expert in regulatory affairs with over two decades of experience in the pharmaceutical industry. Currently, he is the Associate Director of Regulatory Affairs at Micro Labs USA, Inc., where he leads critical regulatory and compliance strategies, ensuring alignment with FDA standards across the product lifecycle.

Gaurang’s career began at Claris Life Sciences Ltd. in India, where he contributed to international regulatory affairs by preparing CMC documents for European dossiers. He then advanced to KVK-Tech, Inc. as a Scientist in Research & Development, gaining hands-on expertise in formulating trial batches and preparing ANDA submissions. At Sunrise Pharmaceutical, Inc., he took on the role of Manager in Regulatory Affairs and R&D, where he managed comprehensive CMC submissions, validation protocols, and lifecycle compliance for pharmaceutical products.

Since 2019, Gaurang has been a cornerstone of Micro Labs USA. He oversees regulatory strategies, compliance initiatives, and FDA communications for generic product approvals. His expertise encompasses managing state licenses, pharmacovigilance systems, drug recalls, and compliance with the Drug Quality and Security Act (DQSA). By ensuring seamless ATP EPCIS data exchange and conducting quality audits with vendors and service providers, Gaurang has established himself as a vital leader in regulatory affairs, prioritizing patient safety and product quality.

Gaurang Bhavsar’s exceptional achievements have earned him widespread recognition in the field of pharmaceutical science. His research interests include regulatory compliance, validation, DSCSA, nitrosamine impurities, microdialysis, anti-fungal activity, and patient safety — areas where his contributions have significantly advanced the pharmaceutical industry.

He holds the prestigious Regulatory Affairs Certification (RAC), reflecting his comprehensive expertise in regulatory processes. Gaurang has been recognized as a "RegEx Pro," “RAPS Champion,” and "RAPS Mentor" by the Regulatory Affairs Professional Society (RAPS) for his knowledge-sharing contributions. Additionally, the American Association of Pharmaceutical Scientists (AAPS) has named him a “Silver Contributor” for his leadership in regulatory science.

Gaurang has actively shaped industry standards by serving as a panelist on DSCSA compliance alongside wholesalers and dispensers and participating as a poster abstract screener for the National Biotechnology Conference. He has also inspired the next generation as a guest speaker at the AAPS Foundation Symposium, emphasizing the importance of pharmaceutical science to advanced-placement high school students.

Through his leadership, expertise, and dedication, Gaurang Bhavsar continues to drive advancements in regulatory science, product development, and patient safety, solidifying his position as a thought leader in the pharmaceutical industry.