15 years of experience across public and government (FDA) sectors with an MBA in biotechnology and an MS in biochemistry. Global experience leading reg strategy with drugs (NCE, line extensions, drug: drug codev, biologic products, and combination products [drug: device]), in all dev phases including filings, and multiple Advisory Committee Meetings. Experience in multiple TAs including Neuroscience, Pain, Inflam/Immunology, CV and Renal, GI, and Rare Disease.