Apurve Dhariwal has significant experience in regulatory affairs working in groups such as strategy, Chemistry Manufacturing and Controls, Quality, and Operations for commercial and development products in the rare and generic drug space. He is experienced in the cross-functional preparation of pre- and post- approval regulatory submissions with a strong understanding of the drug development process and has a firm understanding of health authority regulations. Apurve has successfully contributed to various INDs and BLAs (MAA). He has an extensive knowledge of working with different regulators and has spent time working in quality assurance. The scope of his work has included leading implementation of validated tools, vendor management, audit and inspection. He has worked with biopharmaceutical companies such as Alexion Pharmaceuticals and Genzyme.
Mr. Dhariwal has a Bachelor’s in Pharmacy from Oriental University, India and an M.S. in Regulatory Affairs in Drugs, Biologics and Medical devices from Northeastern University, Boston.