China General Manager, CFDA and Clinical study Expert
CFDA and Clinical study Expert
Stephanie Huang is general manager of Qserve Group China since its establishment. Besides her management role, in which she is developing regulatory strategies, performs gap analysis, strengthens east-west connections within Qserve as well as in the companies served by Qserve China, she focusses on China CFDA compliance in medical devices field. Graduated with MCom from the University of Sydney, she has spent several years studying and working in China, UK, and Australia.
Before joining Qserve in 2012, She worked for a British pharmaceutical contract research organization (CRO) based in Nanjing, and was involved in project management on pharmaceutical and medical device products, and targeted suitable partners for both western and eastern clients. By connecting and leveraging stakeholders’ strengths, she supported a number of companies to extend activity scope and technology capabilities on clinical research development.
She is familiar with local pharmaceutical and medical device industries, regulatory and cultural environment. Stephanie combines an in-depth understanding of CFDA requirements with excellent communication skills.
“Qserve is a multi-national consulting company with people from various cultures and backgrounds, which helps us to understand diversified clients better. My team and I enjoy working together and are very proud of assisting clients at home and abroad with high-quality standards, speeding up their market access, and ensuring compliance with local requirements throughout the product lifecycle at the same time. Keeping pace with fast-changing China and global regulatory updates, and state of art technology makes each daily alive, and enrich the whole professional life. Working in such vigorous environment is a mixed feeling of growth, challenge, and fulfillment”.
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