Yajie Li

Yajie is a senior scientific leader possessing a unique blend of clinical development, regulatory strategy and thought leadership focused on pharmaceutical development. Yajie leads China regulatory strategy consultation, responsible for providing strategic technical guidance on various clinical and regulatory aspects of drug development. Yajie has over 20 years of clinical and drug development experience that includes hospital clinical practice, R&D experience in big and start-up pharma companies, China NMPA Clinical review experience, and regulatory consulting experience in a global CRO.

Work experience

Prior to joining Parexel, Yajie had more than 10 years of experience in the pharmaceutical industry, serving as director, department head and Vice President of clinical, regulatory,  strategy and pipeline management for Merck (China), Innovent (Suzhou), Johnson & Johnson (China), and Xuanzhu Pharm. Her responsibilities included developing and implementing clinical and registration strategies, identifying and mitigating the risks.

In addition, Yajie has worked as a senior clinical reviewer in the Center for Drug Evaluation (CDE) of the CFDA (now NMPA) for nine years. Yajie has reviewed thousands of IND, NDA, ANDA, BLA and supplementary application materials.

Yajie’s therapeutic experience covers oncology, infection disease, cardiovascular, endocrine, digestive disease, and ophthalmology.  

Education

Yajie got her M.D. from Beijing Medical University, and majored Rheumatology and Immunology in Peking Union Medical College (PUMC).