Haimin Buergin
About Haimin Buergin
Haimin Buergin is the Head of Regulatory Affairs Europe at BeiGene, with over 20 years of experience in the pharmaceutical industry, specializing in biologics and small molecules.
Current Role at BeiGene
Haimin Buergin is currently serving as the Head of Regulatory Affairs Europe at BeiGene. He has been in this role since October 2019 and is based in Basel und Umgebung, Schweiz. His duties involve overseeing regulatory efforts across Europe, ensuring compliance with regional health regulations, and strategizing for drug approval and lifecycle management.
Previous Experience at Takeda
Before joining BeiGene, Haimin Buergin worked at Takeda (formerly Shire Pharmaceuticals) from 2014 to 2019. During his five-year tenure in Zug, Switzerland, he served as the Global Regulatory Lead for Neuroscience and Rare Diseases (Orphan drugs). His role was critical in driving regulatory strategies for new drug applications and managing the approval processes for treatments targeting rare conditions.
History with Novartis
Haimin Buergin spent 13 years at Novartis from 2001 to 2014, working as the Global Program Regulatory Director in the Basel Area, Switzerland. Here, he led regulatory programs that spanned multiple therapeutic areas, from cardiovascular to oncology. His responsibilities included global registration and post-approval life cycle management, significantly contributing to the success of various drug development projects.
Educational Background in Molecular Biology and Biochemistry
Haimin Buergin holds a PhD in Molecular Biology from Universität Basel, earned from 1988 to 1992. He also has a Bachelor of Science (B.Sc.) and a Master's degree in Biochemistry from 华东理工大学 (East China University of Science and Technology), where he studied from 1982 to 1986. His strong academic background laid a foundation for his extensive career in pharmaceutical research and regulatory affairs.
Comprehensive Experience in the Pharmaceutical Industry
With over 20 years of experience in the pharmaceutical industry, Haimin Buergin possesses expertise in both biologics and small molecules. He has a robust portfolio of handling drug development, global registration, and post-approval life cycle management across diverse therapeutic areas including cardiovascular, arthritis, analgesia, inflammation, respiratory, immunology, oncology, and rare orphan diseases. He has effectively interacted with worldwide Health Authorities and Health Technology Agencies, managing various regulatory processes such as clinical trial applications and FDA/EMA/MHRA inspections.