Our Team

Ms. Nupur Dutta Chowdhury is a regulatory affairs and clinical research professional with multidisciplinary experience spanning regulatory strategy, clinical operations, human subject protections, and academic research. Her career reflects a progressive transition from patient-focused research into complex regulatory affairs, supported by a strong academic foundation in Sociology and Gerontology and complemented by SOCRA (CCRP) certification and formal regulatory affairs training.

Most recently, Ms. Dutta Chowdhury served in regulatory affairs consulting roles supporting pharmaceutical and biotechnology programs through Parexel and Leidos Life Sciences. At Parexel, she coordinated IND submissions, amendments, annual reports, and lifecycle management activities across diverse therapeutic areas including oncology, rare diseases, and gene therapy programs. She contributed to eCTD submission planning, regulatory publishing coordination, and preparation of FDA briefing materials for pre-IND and other regulatory meetings. Her work required close collaboration with cross-functional clinical, CMC, and nonclinical teams to ensure submission readiness, regulatory compliance, and alignment with FDA and ICH requirements. Through Leidos Life Sciences and federally supported programs, she further strengthened her expertise in regulatory documentation, project coordination, and compliance-driven operations.

Prior to transitioning fully into regulatory affairs, Ms. Dutta Chowdhury held clinical research positions across oncology, trauma research, pediatric neurology, autism research, and ageing-related studies. She supported investigator-initiated trials at Levine Cancer Institute, where she contributed to protocol development, informed consent drafting, eCRF development, and collaboration with sponsors and research personnel. At the University of Maryland Medical System and in support of U.S. Air Force trauma readiness programs, she managed IRB submissions, regulatory compliance activities, research databases, and protocol-related documentation within highly regulated federal research environments. Earlier academic roles at the University of Arkansas for Medical Sciences involved participant recruitment, informed consent, REDCap database management, protocol drafting, and National Institutes of Health (NIH)-supported research coordination.

Nupur’s professional trajectory demonstrates adaptability, scientific curiosity, and a sustained commitment to advancing patient-centered research and regulatory excellence.