Nirdosh Jagota, PhD

Dr. Nirdosh kumar Jagota has more than 30 years of regulatory and quality experience at senior executive levels with global responsibilities. He has led large global teams located in US, Europe, Asia pacific, Latin America, China, India and Japan for successful submission, approval and life cycle management of biologics, small molecules and Vaccines. Dr Jagota is an expert in process simplification and efficiency gain in regulatory and quality processes, resulting in savings of tens of millions of dollars for the sponsors. Dr. Jagota has been responsible for global market application submission and approval of more than 25 small molecules, biologics and vaccines. Dr. Jagota also has the experience of submitting more than two thousands post approval variations and more than 100 INDs . Before establishing GRQ Dr. Jagota was Vice president of global Quality at Amgen. Prior to joining Amgen, he was Senior VP of regulatory and safety at Ocugen, Arcuturs, and Merck respectively. Before joining Merck, he was VP of Regulatory CMC at Genentech Inc. and Pfizer (formally Wyeth). Dr. Jagota also held positions of increasing responsibility at DuPont, Sanofi and BMS in both drug development and Regulatory CMC. Dr Jagota is also a well known expert in area of compliance. He is known internationally for his work in the area of quality by design, regulatory and compliance. He has been the past chair of regulatory sections of American Association of Pharmaceutical Scientists (AAPS) and the International Society for Pharmaceutical Engineering (ISPE). He has also been active in the Drug Information Association (DIA) and was co-chair of the quality section of DIA for three years.