Lei (Ellie) Zhang
About Lei (Ellie) Zhang
Lei (Ellie) Zhang is a Senior Regulatory Affairs Manager at BeiGene with over a decade of experience in the registration of IVD products.
Current Position at BeiGene
Lei (Ellie) Zhang currently holds the position of Senior Regulatory Affairs (RA) Manager at BeiGene. She is responsible for overseeing regulatory strategies, ensuring compliance with relevant regulations, and managing the registration of in vitro diagnostic (IVD) products. Her role involves close collaboration with global teams to navigate complex regulatory landscapes.
Previous Experience at Cepheid
From 2015 to 2020, Lei (Ellie) Zhang worked as a Regulatory Manager at Cepheid in Beijing, China. Her responsibilities included ensuring regulatory compliance for IVD products, managing product registrations, and liaising with regulatory bodies. Her five-year tenure at Cepheid contributed significantly to her expertise in international regulatory affairs.
Roles at bioMérieux and Siemens Healthineers
Prior to her position at Cepheid, Lei (Ellie) Zhang served as a Regulatory Affairs Supervisor at bioMérieux for one year from 2014 to 2015 in Beijing. She also worked for Siemens Healthineers as a Regulatory Affairs Specialist from 2010 to 2015. During these roles, she honed her skills in regulatory compliance and product registration, specializing in IVD reagents and instruments.
Educational Background in Medical Sciences
Lei (Ellie) Zhang holds a Master's degree in Pathogen Biology from Peking Union Medical College, where she studied from 2006 to 2009. She also earned a Bachelor's degree in Clinical Medicine from Hebei Medical University, completing her studies from 1999 to 2004. Her strong academic background in medical sciences underpins her career in regulatory affairs.
Expertise in IVD Product Registration
With over a decade of experience, Lei (Ellie) Zhang specializes in the registration of in vitro diagnostic (IVD) reagents and instruments/software. She is adept at assessing National Medical Products Administration (NMPA) regulations and communicating these effectively to global teams. She has a proven track record in developing strategies and addressing complex regulatory challenges.