Rose Yu
About Rose Yu
Rose Yu serves as the Chief Regulatory Officer for Global Regulatory Science at AffaMed Therapeutics and is a member of the Core Leadership Team. With over 22 years of experience in regulatory roles across Greater China and the Asia Pacific region, she has held senior positions at several prominent companies in the healthcare sector.
Work at AffaMed Therapeutics
Rose Yu serves as the Chief Regulatory Officer for Global Regulatory Science at AffaMed Therapeutics. She is a member of the Core Leadership Team and has held this position since 2021 in Beijing, China. In her role, she oversees regulatory strategies and ensures compliance with global regulatory requirements, contributing to the company's mission in the therapeutic landscape.
Education and Expertise
Rose Yu has an extensive educational background. She studied at Zhejiang University, where she earned her Doctor of Medicine (MD) degree in Clinical Medicine from 1982 to 1987. She furthered her studies at Fudan University, obtaining a Master of Medicine in Immuno-Pharmacology from 1990 to 1994. Additionally, she completed an Executive Master of Business Administration (EMBA) at China Europe International Business School (CEIBS) from 2012 to 2014. In 2017, she participated in the Top Executive Program at Harvard Business School Executive Education.
Background in Regulatory Affairs
Rose Yu has over 22 years of experience in leadership roles within the regulatory affairs sector. Her career includes significant positions at various multinational companies. She worked at Hologic, Inc. as VP of Regulatory & Medical/Clinical and Quality for Asia Pacific from 2017 to 2021. Prior to that, she held roles at Baxter International Inc., Fresenius Kabi, and GlaxoSmithKline, among others, focusing on regulatory compliance and pharmacovigilance in Greater China.
Leadership Experience
Throughout her career, Rose Yu has demonstrated strong leadership capabilities, managing teams of up to 70 individuals. She has held senior positions across Greater China and the Asia Pacific region, contributing to strategic regulatory initiatives. Her experience spans various aspects of regulatory science, including compliance, quality assurance, and medical affairs, which are critical in the healthcare and pharmaceutical industries.
Professional Qualifications
Rose Yu holds dual qualifications as a Medical Doctor and a Certified Pharmacist. This unique combination of qualifications enhances her expertise in regulatory affairs, allowing her to bridge the gap between clinical practice and regulatory compliance. Her extensive background in medicine and pharmacology supports her leadership in global regulatory science.