Diane Hustead (She/Her)

Executive Director, Global Regulatory Affairs & Clinical Safety


Diane Hustead is an advanced regulatory affairs expert and drug shortage prevention industry leader with enthusiasm and dedication to pharmaceutical manufacturing excellence. With a diverse career path and continuously increasing responsibility over her 25 years at Merck, she has extensive expertise within Regulatory Affairs (CMC, various therapeutic areas, labeling, regulatory operations) and Quality Auditing (manufacturing). Diane currently leads regulatory affairs at Merck for US product shortages, discontinuations, import/export activities and regulatory innovation, and has developed business continuity plans for large-scale disruptive events. Additionally, she is the chair of the ISPE Drug Shortage Initiative Team.