Liu Yanwei, who has 19+ years of work experience in the pharmaceutical industry, is Senior Regulatory Affairs and PV director of JW Therapeutics (Shanghai) Co., Ltd. now. She is responsible for tracking and studying development of the most advanced technologies in Europe and America, including cooperating with global research, conducting scientific screening to determine the medical products suitable for the Chinese market, and establishing product development strategies, market access and flow management, with an aim to ensure the latest medical products can be used to serve Chinese patients as early as possible. Besides, she is also fully responsible for cooperating with China health authorities to discuss and share the world advanced technologies, the latest medicine management methods, and innovative studies of the risk control and supervision.
Before joining JW, Ms. Liu Yanwei worked at the management positions in the world top 500 multinational pharmaceutical companies, and completed many International Multicenter Clinical Trial in several therapeutic fields including oncology, immunity, nervous system, multiple sclerosis and urology. Many of the products have been approved to be marketed by the US Food and Drug Administration (FDA) and China Food and Drug Administration (CFDA), which brings new opportunities in the treatment of patients in China and the whole world and saves the life of many patients. In the meanwhile, in the process of application and implementation of International Multicenter Clinical Trial, she also contributed in promoting China's medical and clinical management and studies to achieve the advanced level in the world. She once visited Europe together with the work team of CFDA to learn the drug administration system of the EU. She also led the on-site Inspection Team of the CFDA to visit the biopharmaceutical companies in Belgium and Ireland for on-site investigation and research, where she had comprehensive on-site inspection and discussions about the biopharmaceutical companies with an aim for mutual exchange. In 2005, Ms. Liu Yanwei worked in the headquarters of JNJ in Asia Pacific area in Singapore, participating in the approval of many research & development projects, and cooperating with the R&D center in the US to screen out the projects suitable for the markets in the Asia Pacific and put these projects in the real market to serve the patients. Ms. Liu Yanwei has rich managerial experience in registration and marketing of new products in the Asia Pacific area.
In the past 19+ years of careers, Ms. Liu Yanwei participated in many research & development projects; more than 60 small molecule and biologics products submitted by her in China were approved. She has profound knowledge in medicine management and the pharma industry, knows very well various technical guidelines, including the drug control law, drug registration management method, special evaluation process, biosimilar, ICH, quality management, and import and export management, and has managerial experience in drug variations.
In March 2016, Ms. Liu Yanwei was given the CEO award, Alpine Award, in the headquarters of Genzyme Corporation in Boston. This prize is granted to the excellent employees who have persistent spirit, outstanding leadership and selfless team spirit each year. In the opinion of Genzyme Corporation, these characters are indispensable for a leader to lead a company to succeed. This is the supreme award in Genzyme Corporation and is given personally by CEO of Genzyme Corporation, Mr. David Meeker.
Ms. Liu Yanwei graduated from Lanzhou University in 1996, major in analytical chemistry, and obtained the Bachelor of Science degree.