Mr. Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy, the Directorate comprising the Office of Regulatory Affairs and the Office of International Programs. Mr. Sklamberg provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities.
Prior to being named Deputy Commissioner in January 2014, Mr. Sklamberg served for one year as Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER). He led the Office in its efforts to protect the American public from unsafe and ineffective drug products. Mr. Sklamberg played key leadership roles in global drug supply chain security, pharmacy compounding oversight, pharmaceutical quality, and expanded cooperation with international regulatory partners.
Mr. Sklamberg also served as FDA’s Deputy Associate Commissioner for Regulatory Affairs in the Office of Regulatory Affairs (ORA) from July 2011 until he joined CDER in January 2013. Prior to that, he was Director of ORA's Office of Enforcement. Mr. Sklamberg’s work in ORA led to the development and use of the Food Safety Modernization Act’s new enforcement tools.
Before coming to FDA, Mr. Sklamberg was a federal prosecutor serving as deputy chief of the Fraud and Public Corruption Section in the United States Attorney’s Office for the District of Columbia, as an Assistant U.S. Attorney in that office, and as a trial attorney in the Justice Department's Public Integrity Section. He specialized in the prosecution of white-collar crime.
Mr. Sklamberg graduated from Harvard Law School, received a bachelor’s degree in economics and political science from Yale University, and earned a master’s degree from the Fletcher School of Law and Diplomacy.