Dr. Linda Yang, was until recently associate director, regulatory affairs for Norgine Pharmaceutical. She has spent last 19 years working for pharmaceutical companies and is an expert in regulatory and quality compliance. She has broad background and playing leadership role in functional areas such as product development, business process optimization, quality compliance, clinical development, and regulatory strategy. She had hands on experience on global regulatory management and submission. Currently as independent consultant, she provides directions for regulatory strategy, regulatory submission, clinical studies, CMC requirements for different development stages, product indications, and labeling.

She has experience working with US, European and other global regulatory regulations. She co-authored the book of the Fundamentals of US Regulatory Affairs (2009). Dr. Yang currently teaches regulatory affairs and compliance for University of Berkeley extension, and regulatory and pharmaceutical development for Pharmaceutical Training Institute (PTI).

Dr. Yang obtained her Ph.D in 1992; MBA in 2004; certifications of Regulatory Affairs and Quality Auditor in 2009.