Mary Ellen  Cosenza

Mary Ellen Cosenza, PhD, DABT, ATS, RAC

Adjunct Assistant Professor

Regulatory and Quality SciencesCurriculum Vitae

Contact Information


M.S. Regulatory Science, 2008
USC School of Pharmacy

Ph.D. Toxicology, 1994
M.S. Toxicology, 1986
St. John's University, Queens, NY
Dissertation: Lipid Peroxidation as a Mechanism of Developmental Toxicity in a Micromass Assay System

B.A. Biology (minor in Chemistry) 1981
Queens College, CUNY

Mary Ellen Cosenza


As President of MEC Regulatory and Toxicology Consulting, LLC, Mary Ellen Cosenza is a consultant specializing in early and late stage product development and regulatory strategy and advice to Biopharmaceutical developers. She helps clients with respect to their investments in clinical and non-clinical development programs that will lead to safer and more effective products, and help to achieve optimal global market access.

Prior to her current role, she held leadership positions at AMGEN for 20 years, most recently as Executive Director, U.S. Regulatory Affairs for AMGEN Global Regulatory Affairs and Safety (GRAAS), providing management and leadership by overseeing the execution of and by providing advice on the development of regulatory strategy and plans for the FDA across all therapeutic areas (40+ programs).