A Regulatory Science professional with broad experience authoring successful submissions for DMFs, VMFs, INDs, NDAs and ANDAs. Birju is proficient in providing regulatory advice and strategy for pre-IND through post-approval regulatory phases with extensive experience in assessing general regulatory, nonclinical and clinical documentation in support of global regulatory submissions. Over 19 years cumulative experience with a focus on Quality Systems, cGMPs and regulatory affairs with an emphasis on Chemistry, Manufacturing and Controls (CMC) regulatory technical writing. Demonstrated success leading/coordinating teams on global projects.
Birju gained regulatory science experience through his work at Genpact Pharmalink and Unigene Laboratories and prior to that in Analytical Development and Quality Control roles whilst at International Trading Pharmaceutical Laboratories.
Birju gained a B.Sc. in Cell Biology and Neuroscience from Rutgers University and a Masters in Drugs, Biologics and Medical Devices in Regulatory Affairs from Northeastern University. He also previously held a RAC Certification
Birju is based in our Somerville, New Jersey office.
