ΰͯ ÖÓ has a comprehensive work experience in regulatory affairs in the pharmaceutical industry. They started their career in 2015 as a Future Leader Development Associate at a pharmaceutical company. From July 2015 to November 2016, they served as a Regulatory Affairs Associate. In this role, they gained experience in regulatory affairs management and training. They then joined Pfizer in December 2016 as a Senior Regulatory Affairs Associate II. After working there for a brief period from December 2017 to February 2018, they moved to Zailab in April 2018. At Zailab, they worked as an Associate Regulatory Affairs Manager, managing regulatory projects related to chemical drugs, biological drugs, and medical devices. They also gained experience in device marketing application and successfully submitted three Investigational New Drug (IND) applications. Their most recent role is as a Regulatory Affairs Manager at Reistone Biopharma since June 2020, where they have been responsible for managing and executing INDs in and out of China, supporting US IND submissions, and executing CN IND submissions. Overall, they have a solid background in regulatory affairs, with experience in IND submissions, device marketing applications, and regulatory project management.
ΰͯ ÖÓ has an education history that includes a Bachelor's degree in Medicine from Fudan University, where they studied from 2009 to 2013. They also pursued a Master's degree in Translational Medicine at the University of Liverpool from 2013 to 2014. In terms of additional certifications, they obtained a certificate in "Neural Networks and Deep Learning" from Coursera in June 2022.
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