Donna Little has more than 29 years of experience providing strategic CMC, nonclinical, and clinical regulatory leadership across global development programs. She is skilled in preparing and managing high-quality regulatory submissions, evaluating and mitigating risks, and guiding interactions with global health authorities.

Her expertise includes regulatory strategy for manufacturing, analytical, and supply chain programs. Donna holds a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, along with graduate certificates in international regulatory affairs and medical device regulation. She earned her BA in Biology with a concentration in Biotechnology from Assumption College.