SVP, Regulatory Affairs & Quality
Shamim Ruff is the senior vice president of regulatory affairs and quality at Stoke Therapeutics. Ruff has extensive knowledge of drug development with more than 25 years in the biopharmaceutical industry, working with a diverse range of therapeutics including small molecules, monoclonal antibodies, oncolytic viruses, oligonucleotides and gene therapy. Her expertise in both domestic and international regulatory affairs spans early and late development across multiple therapeutic areas. Prior to joining Stoke, she was the chief regulatory affairs officer at Sarepta Therapeutics, where she built the company’s regulatory affairs and quality organizations and was responsible for leading and defining the regulatory strategy for the company’s rare and infectious disease pipelines. Prior to joining Sarepta, Ruff served as vice president, head of regulatory affairs oncology at Sanofi-Genzyme, where she was responsible for leading the global, European and CMC regulatory affairs teams. She previously held senior positions at Amgen, Abbott and AstraZeneca where she had global oversight for the development and filings of multiple successful regulatory approvals. Ruff holds a BSc. in chemistry and biology from the University of Leicester, UK, and an MSc. in analytical chemistry from the University of Loughborough, U.K. Additionally, she is a chartered chemist and member of the Royal Society of Chemistry (CChem MRSC), and is also a member of ASCO and ASGCT.