Nora Roselle

President, U.S. Regulatory Affairs
Dr. Roselle joined DSI - Rockville as Managing Director of U.S. Regulatory Affairs in 2007, promoted in 2012 to Vice President, U.S. Regulatory Affairs and most recently promoted to President, U.S. Regulatory Affairs. Prior to DSI, she served as an officer (LCDR) in the U.S. Public Health Service. She joined the U.S. Food and Drug Administration (FDA) in 2001 as a Safety Evaluator in the Division of Medication Errors and Technical Support (DMETS), in the Office of Drug Safety (ODS), renamed the Office of Surveillance and Epidemiology (OSE), now known as the Division of Medication Error Prevention and Analysis (DMEPA). DMEPA is responsible for the approval of manufacturer’s drug/biologic brand names and human factors/ medication error evaluation of drug and drug/device labeling, packaging, and product design to reduce medication errors.

As Team Leader, Dr. Roselle managed DMETS safety evaluators, proprietary (brand, line extension, and combination product) name reviews, labeling and risk management consults. Dr. Roselle has published several articles on medication errors. Two of her most widely known name safety articles include “Metadate ER or Metadate CD?; Drug Topics 2004,Oct 11:62,64” and “Confusion between Methylphenidate and Methadone, Patient Care 2003, Jan 15:76.” Dr. Roselle earned a Doctor of Pharmacy from the University of Maryland (with Honors) and a B.S. in Biology with a Chemistry Minor from the University of Akron (Cum Laude).