Mary Ellen Cosenza, PhD, DABT, ATS, ERT, RAC is a regulatory consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets.
Most recently, Mary Ellen served as Executive Director, U.S. Regulatory Affairs, at Amgen, Inc. During her 20-year tenure at Amgen, she led the International Emerging Markets Regulatory Department and served as Executive Director of Global Regulatory Affairs and Safety. In addition to her leadership and expertise in Regulatory Affairs, she is also recognized as an expert in preclinical biologic drug development and served as Senior Director of Toxicology at Amgen.