.jpg "Nirali Dholaria, MS photo")
PhD Graduate Student- Pharmaceutical Sciences
Ernest Mario School of Pharmacy, New Jersey
Nirali Dholaria, MS, BS (Pharmacy), is a Regulatory Affairs professional with over 12 years of specialized experience in regulatory CMC for small molecules, sterile products, and drug–device combination products. She earned her Master’s degree in Drug Regulatory Affairs from Long Island University, New York, and is currently pursuing a PhD in Pharmaceutical Sciences at Rutgers University, New Jersey (anticipated 2026).
Ms. Dholaria has extensive expertise in preparing and managing global regulatory submissions, including INDs, NDAs, ANDAs, and MAAs, as well as post-approval variations for diverse dosage forms such as injectables, ophthalmic emulsions, inhalation products, transdermals, and oral formulations. Her therapeutic area experience encompasses oncology, respiratory, antivirals, pain management, ophthalmology, and metabolic disorders. She has successfully engaged with multiple health authorities worldwide, including the US FDA, EMA, PMDA-Japan, Health Canada, and others, providing strategic guidance to ensure compliance and timely approvals.
Currently serving as Senior Scientist in Global Regulatory Affairs–CMC at Organon LLC, Ms. Dholaria leads regulatory strategy and lifecycle management for established brands across international markets. She is also an active researcher, having co-authored peer-reviewed articles and book chapters on artificial intelligence in drug delivery and nanotechnology-based transdermal drug delivery systems.
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Keynote: Creating Community Connections to Enhance Clinical Research
Tuesday, November 11, 2025
1:30 PM - 2:30 PM CT