Lisa Yan, PhD, Rac
About Lisa Yan, PhD, Rac
Lisa Yan, PhD, Rac, is the Sr. Manager of Regulatory Affairs at BeiGene, with extensive experience in regulatory compliance, quality assurance, and microbiology management.
Title
Lisa Yan serves as the Sr. Manager of Regulatory Affairs at BeiGene. Her role focuses on regulatory compliance and navigating submission processes for novel therapies. She directs and oversees various regulatory strategies to ensure product approvals.
Company
Lisa Yan is currently employed at BeiGene, a global biotechnology company specializing in innovative cancer treatments. At BeiGene, Lisa leads a team to manage complex regulatory submissions and ensure compliance with international standards.
Past Employment at Amgen
Lisa Yan worked at Amgen from 2019 to 2022 as the Sr. Manager, External Supply Quality Site Lead. During her time there, she oversaw quality assurance for external partnerships and implemented a continuous improvement initiative that cut regulatory submission times by 20%.
Educational Background and Expertise
Lisa Yan holds a PhD in Microbiology and Immunology from the University of Southern California (2009-2013). She also earned a BS in Biochemistry from UCLA (2005-2009). Additionally, she has certificates in Clinical and Translational Science and Regulatory Affairs for Medical Device and Pharmaceutical from USC and the Regulatory Affairs Professional Society, respectively.
Industry Contributions and Mentorship
Lisa is actively involved in mentoring junior professionals through the Regulatory Affairs Professional Society's mentorship program. She has contributed significant research to regulatory compliance and quality assurance, authoring multiple peer-reviewed articles and presenting at notable conferences like the AACR annual meeting.