Lauren Melton, MS, MBA

Lauren Melton, MS, MBA has a range of experience in regulatory affairs and drug development. Lauren is currently the VP and Head of Global Regulatory Affairs at Cardurion Pharmaceuticals. Prior to this, they held the role of VP and Head of Regulatory Affairs at Xilio Therapeutics, where they oversaw global regulatory affairs, medical writing, quality systems management, and pharmacovigilance. At Alnylam Pharmaceuticals, they served as a Senior Director and Program Leader, leading drug development teams for anti-hypertensive and complement inhibiting molecules. Lauren also provided strategic and operational oversight for various program-related functions. Lauren has also held roles at Vertex Pharmaceuticals, where they were the Director of Regulatory Affairs, and at GE Healthcare as a Strategic Regulatory Marketing Director. Lauren has experience in global regulatory activities, leading teams, and representing regulatory affairs with external partners. Earlier in their career, Lauren worked at Genzyme as a Principal Associate Regulatory Affairs and at Biogen Idec and MassBiologics in validation roles. Overall, Lauren Melton has a solid background in regulatory affairs and drug development, with experience in leadership, strategic planning, and regulatory strategy.

Lauren Melton, MS, MBA has a diverse educational background centered around biotechnology and regulatory affairs. Lauren obtained a Master of Business Administration (MBA) with Distinction (Top 10% of Graduating Class) from Cornell Johnson Graduate School of Management between 2015 and 2017. Prior to that, they obtained a Master of Science (M.S.) in Bioscience Regulatory Affairs from The Johns Hopkins University. Additionally, they completed coursework for a Master of Liberal Arts (M.L.A.) in Biotechnology Project Management at Harvard University and earned a Graduate Certificate in Biotechnology Engineering from Tufts University. Lauren also holds a Bachelor of Science (B.S.) in Biology Pre-Med & Psychology from the University of Massachusetts Amherst, which they completed in 2001. In terms of certifications, they have obtained a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS), although the exact date of obtaining the certification is not provided.