Golak Nadery
About Golak Nadery
Golak Nadery serves as the Senior Regulatory Affairs Associate and CMC Asia Markets Lead at Kite Pharma, where he has worked since 2020. He has extensive experience in regulatory affairs, including leading New Drug Application preparations for Japan and China and managing regulatory strategies for international expansion.
Work at Kite Pharma
Golak Nadery currently serves as the Senior Regulatory Affairs Associate and CMC Asia Markets Lead at Kite Pharma, a position held since 2020. In this role, he has led the coordination and preparation of New Drug Application (NDA) marketing applications for Japan and China, focusing on specific modules M2.3 and M3. Previously, he worked as a Project Management Associate from 2018 to 2020, where he prepared Annual Reports and supporting documents for submission to the FDA. His responsibilities included performing life cycle management activities and regulatory assessments across US, EU, and Asia markets.
Education and Expertise
Golak Nadery holds a Bachelor's Degree from the University of California, Santa Barbara, where he studied English Literature (British and Commonwealth) and Global Studies. He furthered his education at Southwestern Law School, earning a Juris Doctor (J.D.) degree with a focus on American/U.S. Law and Legal Studies. His educational background supports his expertise in regulatory affairs, particularly in the preparation of IND amendments and filings, and his thorough knowledge of Common Technical Document (CTD) modules.
Background
Before joining Kite Pharma, Golak Nadery held various positions that contributed to his regulatory and project management experience. He worked as an Executive Assistant to the Vice President at Kite Pharma for eight months in 2018. Prior to that, he served as Program Management Office Lead at SapientNitro from 2015 to 2017. He also gained legal experience as an Executive Legal Assistant at Nella Law Group from 2014 to 2015. His diverse background has equipped him with a comprehensive understanding of regulatory processes and project management.
Achievements
During his tenure at Kite Pharma, Golak Nadery has developed and coordinated complex regulatory strategies aimed at international expansion. He has led project kick-off meetings for major filings and engaged in cross-functional meetings representing Regulatory Affairs Chemistry, Manufacturing, and Controls (RA CMC). He has also streamlined the document review process for electronic documents within the Technical Operations Organization and has experience with regulatory audits from agencies such as the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA).