Responsibilities

Michelle Usher is executive director of regulatory affairs for Furiex. She is responsible for regulatory strategy, liaisons with regulatory authorities and regulatory submissions globally.

Experience

Ms. Usher has more than 22 years of experience in drug development, with the past 17 years in regulatory affairs. Before joining Furiex, she served as PPD’s executive director of regulatory affairs for North America and Latin America and was responsible for the management of the department of regulatory affairs and medical writing. Additionally, with her strong chemistry, manufacturing and controls (CMC) expertise, she assisted with the management of CMC vendors and provided senior regulatory oversight to all compound partnering programs at PPD while supporting the contract research organization (CRO) business.

She has worked for several CROs and a large pharmaceutical organization where she held various positions within global regulatory affairs and research and development.

Ms. Usher has authored and/or managed more than 75 regulatory submissions including clinical trial applications, marketing applications and associated regulatory authority meeting packages

Her experience covers multiple therapeutic areas including metabolic/endocrine, oncology and analgesics.

Education

Ms. Usher has a bachelor’s degree in chemistry from North Carolina State University. She received her regulatory affairs certification (RAC) in 1994.

She is a member of the Regulatory Affairs Professional Society, Drug Information Association and the North Carolina Regulatory Affairs Forum, where she served as president in 2001.