William M. Zoffer

Independent Consultant

William M. Zoffer

Education

J.D. (cum laude), Harvard Law School

Summary of Experience

Mr. Zoffer is an expert in pharmaceutical regulatory law, enforcement, and compliance. Over nearly three decades in both industry and government, he gained deep experience through roles at GlaxoSmithKline (GSK) and the US Department of Justice (DOJ). His executive-level experience, including a decade of service as a member of leadership teams managing GSK’s global R&D and US pharmaceuticals commercial organizations, has given him a keen knowledge of business context and industry norms.

Mr. Zoffer spent more than 20 years at GSK, where he led divisions of the legal department dedicated to supporting global drug discovery and development, as well as prescription drug and vaccine commercialization in the US and globally. His leadership and oversight responsibilities at GSK encompassed a wide array of legal and regulatory aspects of selling and marketing prescription drugs and vaccines, as well as their discovery and development. Mr. Zoffer’s personal practice emphasis encompassed advocacy and advice on regulatory issues within the Food and Drug Administration’s (FDA’s) jurisdiction. These issues included brand and generic drug approval standards; promotional practices; safety/risk management; and good laboratory, clinical, and manufacturing practices.

Prior to joining the legal team at GSK, Mr. Zoffer worked for seven years as a trial attorney at the DOJ, in the Office of Consumer Litigation. He litigated and investigated matters related to the FDA, in both civil and criminal proceedings. In addition to his practical experience, Mr. Zoffer has also taught food and drug law at the Duke University School of Law.

AG Contacts

Pierre Y. Cremieux