Faegre Drinker announced today that leading regulatory attorney Joy Sharp has joined the firm as counsel in Washington, D.C. She joins the firm from the United States Food and Drug Administration (FDA).
Sharp is a passionate advocate for clients navigating policy and operational decision-making given the legal and regulatory complexities of today’s public health law and policy. With 15 years of experience in the Food and Drug Administration, Sharp brings a wealth of specialized legal and regulatory knowledge to the table for regulated industry, particularly manufacturers of drugs, biologics, medical devices and combination products; importers of food and other regulated products; and companies seeking to optimize and market platform technologies, secure supply chains and meet quality expectations.
With many years of in-house general business practice experience, advising senior executives on corporate legal policy and in niche aspects of transportation law, Sharp is adept at helping clients maneuver challenging situations by providing seasoned legal guidance on regulatory requirements and Agency processes.
“With deep experience from her years working across the FDA, Joy brings tremendous knowledge in regulatory decision-making and agency relationships,” said Dave Zook, leader of the firm’s government and regulatory practice group. “Joy is an important addition to our commitment to serving FDA-regulated industries and we’re excited to introduce her to our clients.”
While at the FDA, Sharp advised on many aspects of drug and biological product policy, including inspectional authority, matters of product jurisdiction, scope of statutory authority and applicability of current regulatory regime to various Agency initiatives; the Agency’s platform technology designation program; and quality metrics and quality management maturity initiatives. She also advised senior imports and field leadership in the areas of imports review process, sampling strategy, import alerts and administrative detention, prior notice and Automated Commercial Environment data set and process requirements.
Prior to her work with the FDA, Sharp spent nearly a decade providing legal guidance in the transportation and logistics industry. She drafted and implemented the security protocol for 135 distribution centers; advised the fleet safety director for the then-largest private fleet of tractor-trailers in the world; and negotiated vehicle leases, freight-forwarding/logistics contracts and corporate airplane sales.
Sharp earned her bachelor’s degree from Johns Hopkins University and her Juris Doctor from the University of Maryland School of Law.