Margaret E. Hurley, M.D.

Susan M. Mondabaugh, Ph.D.

Vice President, Regulatory Affairs

Susan M. Mondabaugh, Ph.D. is Vice President of  Regulatory Affairs at Hurley Consulting.  Dr. Mondabaugh has over thirty years experience in the pharmaceutical industry, the last seventeen years of which were in regulatory affairs related to both drugs and devices.  Her specific expertise includes IND and NDA submissions for drugs and 510(k), IDE, and PMA submissions for devices.  She has had extensive experience in International MAAs, FDA negotiations, and Advisory Panel preparation.  Specific therapeutic areas for submissions have included metabolism and endocrine, reproductive and urologic, gastrointestinal, cardiovascular, respiratory, anti-infectives, antivirals, inflammation, and opthalmologics.

At Hurley Consulting, Dr. Mondabaugh is responsible for regulatory strategies for submissions, critical review of submission documents, and general regulatory activities related to preparation of client documents.  She advises clients on strategies for regulatory submissions and, at the request of clients, Dr. Mondabaugh will interact with FDA and other health authorities to facilitate review and approval of product applications.

Before joining Hurley Consulting, Dr. Mondabaugh was Director of Global Regulatory Affairs at Pharmacia & UpJohn, Kalamazoo, Michigan.  In this position, she developed and implemented strategies for the submission and timely approval of new products worldwide and the maintenance of existing products.  She directed the activities of a professional staff of seven.   Dr. Mondabaugh was instrumental in obtaining US regulatory approval of Detrol, Zyvox, Fragmin, and Genotropin. 

From 1985 to 1994 Dr. Mondabaugh was employed by Marion Merrell Dow, Inc. first as Team Leader in the Department of Diagnostic Research and later as Senior Technical Advisor, US Regulatory Affairs.  Before this she was Manager, Infectious Disease Program, Ventrex Laboratories, Portland, Maine.

Dr. Mondabaugh began her career in pharmaceuticals as an assistant scientist with Hoffmann-La Roche, Nutley, New Jersey, and rose through scientific levels to Senior Scientist, Roche Diagnostic Systems.  There she developed immunoassays for infectious diseases and drugs of abuse.

Dr. Mondabaugh holds Masters and Doctorate degrees in physiology from New York University and a Bachelor of Science degree in chemistry and biology from Montclair State College, New Jersey.  She is a member of the Regulatory Affairs Professionals Society and the American Society of Clinical Pathologists.