Senior Regulatory Project Manager
CurrentSenior Regulatory Project Manager for the Division of Metabolism and Endocrinology Products, Office of New Drugs II, Center for Drug Evaluation and Research (CDER) Oversees the day-to-day management of innovator's drug products to treat thyroid dysfunction and growth hormone deficiency. Co-leader of the review teamCoordinates the drug review process from initial submission to time of approval.Functions as sole industry contact for regulatory issues related to submitted applications. Responsible for communicating directly with industry counterparts to resolve issues and explain current regulatory requirements.