Ritu NalubolaRitu Nalubola, Ph.D., serves as the Deputy Director of the Office of Policy, Legislation, and International Affairs (OPLIA) in the Office of the Commissioner. In this role, she supports the Deputy Commissioner and OPLIA sub-offices to advance the FDA’s policy, legislative, and global programs, as well as engagements with Congress and global and domestic partners.
Prior to assuming this role, Dr. Nalubola served as the Director of the FDA’s Europe Office, advancing the priorities of both the FDA and the Department of Health and Human Services (HHS) in the region. She led an office that worked across three locations (in Brussels, embedded within the U.S. Mission to the European Union; in Amsterdam, embedded within the European Medicines Agency; and at FDA headquarters in White Oak, Maryland) in strengthening the safety and effectiveness of medical products and food produced in Europe for export to the United States. She also fostered collaborations with counterparts across Europe to promote regulatory alignment and harmonization, particularly in emerging technologies and issues of mutual transatlantic significance. Over the course of Dr. Nalubola’s five-year tenure, the FDA achieved transformative accomplishments in regulatory cooperation with its European and global partners and marked significant milestones in several areas, including biotechnology innovation; mutual recognition agreements between the United States, the EU, the U.K., and Switzerland; the illicit trade in health products; the shellfish equivalence arrangement; and digital health and related data governance.
An FDA veteran of more than two decades, Dr. Nalubola served as a senior policy advisor in the FDA’s Office of Policy in the Office of the Commissioner. In this role, she led FDA’s efforts, in support of the broader U.S. government activities, to modernize the federal regulatory system for biotechnology products. She has been the agency’s voice on this topic in multiple domestic and international forums. She has advised senior leadership at the FDA, HHS, and other U.S. government agencies on complex and crosscutting policy issues, including biotechnology, nanotechnology, food safety, nutrition, and trade-related matters. Dr. Nalubola also played a leadership role in establishing regulations to implement the FDA Food Safety Modernization Act, representing and leading agency delegations in multilateral standards-setting and scientific dialogues.
Dr. Nalubola started her career at the FDA’s Center for Food Safety and Applied Nutrition where she worked on a range of nutrition and food safety policy matters. She earned her doctorate in human nutrition, focusing on nutritional biochemistry, from Michigan State University. She conducted her postdoctoral work at Johns Hopkins University assigned to the U.S. Agency for International Development, where she was involved in setting up international public health programs.