Donna Little, MS

Donna strategically evaluates, communicates, and tracks actual or potential risks/issues across development programs.

Donna has over 29 years of experience providing strategic CMC, nonclinical, and clinical regulatory leadership, guidance, and expertise to ensure that applicable global regulatory requirements are considered and strategically incorporated into development programs. She has planned and managed activities to prepare high-quality global regulatory submission elements, including authoring or critical review to ensure compliance with global regulatory requirements, scientific excellence, accuracy, source information traceability, and consistency with related filings per program timelines.

Donna also strategically evaluates, communicates, and tracks actual or potential risks/issues across development programs, providing risk-based solutions to challenging technical issues that support resolution. She also supports the development of manufacturing, analytical, and supply chain strategies and provides expert regulatory guidance to ensure compliance with global regulatory requirements and internal policies and procedures.

She has overseen multiple document developments, including the annual update/DSUR in the US and other global regions as needed, nonclinical and clinical CTD sections to support global submissions, and clinical regulatory documents including but not limited to the investigator’s brochure, pharmacy manual, statistical analysis plan, etc. She has led or supported global Health Authority interactions, including defining strategy, preparation, and meeting facilitation, and managed functional experts tasked with providing timely responses to regulatory questions from global Health Authorities.

Donna received her Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, Boston, MA, and also earned a Graduate Certificate in Biopharmaceutical International Regulatory Affairs and a Graduate Certificate in Medical Devices Regulatory Affairs. Her undergraduate degree is from Assumption College, Worcester, MA, where she earned a BA in Biology with a concentration in Biotechnology.

29+ years of experience providing strategic CMC, nonclinical, and clinical regulatory leadership, guidance, and expertise

Education

• Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, Boston, MA
• Graduate Certificate in Biopharmaceutical International Regulatory Affairs
• Graduate Certificate in Medical Devices Regulatory Affairs
• BA in Biology with a concentration in Biotechnology from Assumption College, Worcester, MA