Nidhi Kotecha, M Pharm, PhD, RAC

Program Director of Regulatory Affairs

Nidhi Kotecha leads Regulatory Affairs at the Gates Institute, where she navigates the complex regulatory frameworks essential for advancing cell and gene therapies from discovery to clinical trials. With a PhD in Pharmaceutical Sciences and Regulatory Affairs Certification (RAC), she combines scientific knowledge with technical and regulatory expertise. For more than a decade, she has sharpened these skills through diverse roles as a scientist, researcher, and quality leader, driving excellence across various stages of the product development lifecycle. Before transitioning to Regulatory Affairs, Nidhi worked at the Gates Biomanufacturing Facility and has been with the Gates for five years. She views regulatory affairs as the critical thread weaving scientific breakthroughs to patient care and thrives on the challenge of integrating regulatory strategy with scientific innovation to ensure safe, effective, and transformative therapies. Outside of work, Nidhi is a volunteer coach for her community’s robotics club and enjoys building LEGOs with her family. Fun fact: Despite her cakes turning out more like science experiments, and confirming her plants prefer other gardeners, she still enthusiastically tries to explore new passions.