•Two Master’s Degrees and Robust Certifications: Molecular Biology and Biotechnology & Regulatory Science. Certified Project Management Professional (PMP); Certified Regulatory Affairs Professional (RAC).
•Proven U.S. Senior Regulatory Affairs Expert: 14 years experience in Regulatory Affairs, past 7 years in early-stage Development. Additional, 8 years experience in CMC development for small molecules, Biologics and combination products.
•Proven Track Record of Regulatory Performance/Execution: NIH Director’s 2021 Merit Award; NIAID 2019 Merit Award; key member of the COVID-19 Vaccine development effort in 2020-2021.
•Proven expertise in the emerging specialty field of biomedical regulatory sciences, drug development, preclinical and clinical research strategies, toxicology, the full range of assay development, process development, and manufacturing strategies.
•Publications records including New England Journal of Medicine, and Lancet.
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