Our Team

Jenny Yang is currently a Regulatory Project Manager at Biologics Consulting Group, with over 10 years of experience in drug development, regulatory strategy, and global regulatory project management across the United States, Canada, and China. In her current role, she supports sponsors in the development of biologics and small molecule products through regulatory strategy, FDA interactions, and submission planning. 

She has extensive experience leading FDA communications and regulatory interactions, including Pre-IND and Type B/C meetings, and supporting a wide range of regulatory submissions such as INDs, and Orphan Drug Designation (ODD) applications. She serves as a primary regulatory contact for sponsor programs, providing guidance across early-phase development and lifecycle regulatory activities, including submission strategy and regulatory pathway planning. 

Prior to joining Biologics Consulting, she worked at BLA Regulatory, LLC as a Regulatory Project Manager, where she managed multiple regulatory programs across global development teams. Her responsibilities included overseeing eCTD submissions, managing agency correspondence, tracking critical project milestones, and supporting cross-functional regulatory project execution. 

Earlier in her career, she gained experience across CMC, preclinical, and clinical research environments, which provided her with a strong foundation for understanding the full drug development lifecycle and effectively supporting regulatory strategy and project execution across multidisciplinary programs. 

She holds a Ph.D. in Pharmaceutical Sciences and a B.Sc. in Pharmacy and has completed additional training in Clinical Research and Regulatory Affairs & Quality Operations (RAQC). She is fluent in English and Mandarin Chinese and has a strong interest in advancing innovative therapies through efficient and science-driven regulatory strategies.