Shamim Ruff joined Sarepta in January 2013 as our Senior Vice President, Regulatory Affairs and Quality.
Ms. Ruff's experience includes more than twenty-five years in the biopharmaceutical industry, working with a diverse range of therapeutics including small molecules, monoclonal antibodies, oncolytic viruses and oligonucleotides. Her expertise in both domestic and international Regulatory Affairs spans early and late development across multiple therapeutic areas, including Rare Diseases, Oncology, Hematology, Antivirals and Bone Therapy Areas and includes extensive interaction with multiple regulatory agencies globally, including FDA (CDER/CBER/CDRH), EMA/CHMP, Health Canada, and PMDA.
Prior to joining Sarepta, Ms. Ruff served as Vice President, Regulatory Affairs at Sanofi where she was Head of Oncology Regulatory Affairs, responsible for leading 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 compounds, some of which had companion diagnostics. In addition, Ms. Ruff has significant experience leading the preparations for FDA Advisory Committee Meetings.
Ms. Ruff holds a Bachelor’s degree in Chemistry & Biology from the University of Leicester, UK, and a Master’s degree in Analytical Chemistry from the University of Loughborough, UK. Additionally, she is a Chartered Chemist and Member of the Royal Society of Chemistry (CChem MRSC), and is also an active member of DIA, RAPS and ASCO.