Nirdosh Jagota on Blogger

About Nirdosh Jagota

Based in Malvern, Pennsylvania, Nirdosh Jagota delivers regulatory and quality solutions as vice president of quality and science at Amgen. Responsible for a more than 100-person team of scientists, Nirdosh Jagota develops project strategies related to the maintenance and filing of products worldwide. He also oversees the preparation for inspection forAmgen's manufacturing plants. Dr. Jagota also has past experience as senior vice president of regulatory, quality, and safety with Ocugen. Guiding a number of FDA meetings, he helped the firm develop a strategy for COVID-19 vaccine development. He also worked to initiate clinical studies within gene therapy programs, as well as a Phase 1 B program. His efforts also enabled the firm to attain regenerative medicine advanced therapy (RMAT) designation within a Phase 3 ready cell therapy program. Dr. Jagota spent 6 years as senior vice president of regulatory affairs with Merck, where he oversaw global regulatory efforts including Japan and China. During this period, he obtained approval of several innovative medicines and vaccines in many countries worldwide. Dr Jagota also built an offshoring and outsourcing function which resulted in savings of tens of millions of dollars.