Chester Chae
About Chester Chae
Chester Chae is a Manager of Regulatory Affairs with extensive experience in regulatory submissions across multiple regions, including the US, EU, and JAPAC. He has held positions at various organizations, including ORIC Pharmaceuticals Inc. and Sorrento Therapeutics, Inc., and has a strong educational background in biotechnology and chemistry.
Current Role at ORIC Pharmaceuticals
Chester Chae serves as the Manager of Regulatory Affairs at ORIC Pharmaceuticals Inc., a position he has held since 2022. In this role, he is responsible for overseeing regulatory submissions and ensuring compliance with industry standards. His work is crucial in facilitating the development and approval of pharmaceutical products. Chester's expertise contributes to the company's efforts in navigating complex regulatory landscapes.
Previous Experience at Sorrento Therapeutics
Before joining ORIC Pharmaceuticals, Chester worked as the Manager of Regulatory Affairs at Sorrento Therapeutics, Inc. from 2021 to 2022. During his tenure in San Diego, California, he focused on regulatory strategies and submissions, enhancing the company's ability to bring innovative therapies to market. His experience at Sorrento provided him with valuable insights into the regulatory processes within the biotechnology sector.
Educational Background in Biotechnology
Chester Chae earned his Master's degree in Biotechnology from Keck Graduate Institute, where he studied from 2017 to 2019. His academic background includes a Bachelor's degree in Chemistry from Hanover College, completed from 2013 to 2017. Additionally, he participated in a Study Abroad program at the University of Wollongong in 2016. This educational foundation has equipped him with a strong understanding of the scientific and regulatory aspects of the pharmaceutical industry.
Expertise in Regulatory Affairs
Chester possesses extensive experience in regulatory submissions across multiple regions, including the US, EU, and JAPAC. He has a comprehensive understanding of various regulatory submission types such as CTA, MAA, IMPD, IND, NDA, BLA, EUA, IDE, 510k, PMA, DSUR, and annual reports. His expertise encompasses managing the life cycle of biological products, small molecule products, and cell therapies, making him a valuable asset in the regulatory affairs domain.
Involvement with PDA - Parenteral Drug Association
Chester has been actively involved with the PDA - Parenteral Drug Association as a member of the SoCal PDA Young Professional Committee since 2020. This role allows him to engage with other professionals in the field, share knowledge, and contribute to discussions on best practices in regulatory affairs and drug development. His participation reflects his commitment to professional development and networking within the industry.