Qi (Tony) Xu
About Qi (Tony) Xu
Qi (Tony) Xu is the Associate Director of Regulatory Affairs at BeiGene, with extensive experience in regulatory affairs and a strong academic background in business, regulatory science, and pharmaceutical sciences.
Company
Qi (Tony) Xu currently holds the position of Associate Director Regulatory Affairs at BeiGene. His role involves leading regulatory submissions and strategies for innovative oncology therapies. He has been with BeiGene since 2019, steadily advancing through various positions within the organization.
Title
As Associate Director Regulatory Affairs, Qi (Tony) Xu oversees global regulatory activities. His responsibilities include the submission and maintenance of IND/BLA/NDS filings, managing FDA meeting preparations, and handling agency correspondences. His leadership is integral to the clinical development stages of novel oncology therapies.
Education and Expertise
Qi (Tony) Xu attained his Master of Business Administration (MBA) from the Haas School of Business at the University of California, Berkeley, from 2020 to 2023. He holds a Master’s Degree in Regulatory Science from Georgetown University and a Master of Science (MS) in Pharmaceutical Sciences from the University of Pittsburgh. Additionally, he is certified in Regulatory Affairs (RAC). Xu's expertise encompasses global regulatory submissions, clinical study design, and post-marketing agency interactions.
Background
Qi (Tony) Xu's professional journey includes key roles across several notable organizations. He served as Sr. Manager and Regulatory Affairs Manager at BeiGene from 2019 to 2023. Prior to that, he was a Senior Regulatory Affairs Associate at Ultragenyx Pharmaceutical Inc. from 2016 to 2019. Xu also gained experience as a Regulatory Program Management Intern at Genentech from 2015 to 2016 and worked part-time as an IRB Program Coordinator at Georgetown University.
Achievements
Qi (Tony) Xu has been recognized as a Global Regulatory Lead for novel oncology therapies in clinical development. He has demonstrated a strong aptitude in global regulatory submissions, including IND/BLA/NDS filings and FDA meeting preparations. His ability to excel academically, personally, and professionally has been a hallmark of his career, showcasing his strong communication skills and learning capacity.