Birju Patel

Birju Patel, MS, RAC, serves as the Director of CMC and Regulatory Affairs Operations at Voisin Consulting Life Sciences (VCLS) since January 2024. With extensive experience in regulatory affairs, Birju has previously held leadership positions, including Director CMC and Regulatory Affairs at B&H Consulting Services, where strategic and technical expertise was provided for drug and medical device development, and supervision of regulatory guidance and submission strategy based on FDA, EU, and ICH guidelines. Prior roles include managing a team at Genpact Pharmalink for global projects and conducting regulatory affairs for Unigene Laboratories, focusing on CMC Drug Substance Type II DMFs and analytical method development. Birju holds a Master’s degree in Drugs, Biologics, and Medical Device Regulatory Affairs from Northeastern University and a Bachelor’s degree in Cell Biology and Neuroscience from Rutgers University.