Xiaofei Song linkedin.com/in/xiaofei-song
■ Career history: Manager - Drug Regulatory Affairs, GSK, China Associate Manager - Drug Regulatory Affairs, Sandoz, China Specialist - Drug Regulatory Affairs, Baxter, China Specialist - Drug Research & Development, Yangzijiang Pharma, China ■ Education highlights: MBA, Warwick Business School, UK MSc, Pharmaceutical Engineering, Dalian University of Technology, China BEng, Pharmaceutical Engineering, Qingdao University of Science and Technology, China
■ Nationality: Chinese
■ Languages: Mandarin Chinese (native) English (fluent)
German (basic)
■ Career achievements: Managed multiple import drug registrations as regulatory subject matter expert at Sandoz (a Novartis company), in collaboration with external and internal stakeholders. Achieved market authorisation for one anti-fungal drug that was finally launched to market in 2021 and won National Volume-Based Purchase bidding, benefiting millions of patients. Liaised with the China Health Authority on the filing strategy for an innovative preventative Meningitis B vaccine in GSK and obtained useful feedback to accelerate the vaccine development, supporting the business case forecast of £50 million for the first year of launch. Maintained life-cycle management of more than 10 import licensed drugs at Baxter. In particular, managed the risk of license renewal for one key product, strongly supporting the company with commercial supply continuity (approximately 200,000 injections were secured in 2017).
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