Chief, Project Management Staff, Office of Regulatory Operations, Office of New Drugs, Office of New Drugs, Center for Drug Evaluation and Research (CDER)
FDA
Ms. Kober is a Chief, Project Management Staff in the Office of Regulatory Operations within the Office of New Drugs, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. In this capacity, Ms. Kober provides supervisory leadership and direction to the project management staff, participates in the development and implementation of policy and strategy for the regulation of reproductive and urologic drug products, and participates in meetings with industry to provide information and advice on policy, law, and regulations.
Previously, Ms. Kober held the position of Regulatory Review Officer in the Division of Drug Marketing, Advertising, and Communications (DDMAC) in CDER. She was responsible for the regulation of promotional activities related to metabolic and endocrine drug products. She has also served as a Team Leader for the Drug Registration and Listing project.
Ms. Kober joined FDA with 15 years of experience in community pharmacy practice and continued to practice in this setting until 2020.
Ms. Kober received her Bachelor of Science degree in Pharmacy from the University of Rhode Island and her Master's degree in Public Administration with a concentration in health policy and administration from George Mason University.
Disclosure information not submitted.
Workshop: Unlocking Best Practices for Sponsors and Regulators in Combination Product Submissions
Wednesday, November 12, 2025
12:30 PM - 3:00 PM East Coast USA Time