DLA Piper LLP (US)

Litigation, Arbitration and Investigations; Product Liability, Mass Torts and Product Stewardship; Regulatory and Government Affairs; FDA; Life Sciences; Healthcare

Associate

Jae Kim is an associate in DLA Piper's FDA Regulatory Group, and advises clients in the life sciences, food and beverage, hemp and CBD, and consumer products industries.

Jae provides regulatory compliance and risk management advice to companies with products and operations subject to regulation by FDA, USDA, TTB, DEA, and FTC, as well as state regulatory authorities. Her broad regulatory practice encompasses medical devices, drugs (prescription and OTC), dietary supplements, food and beverage, alcohol, hemp and CBD products, and cosmetics.

As part of her regulatory practice, she regularly counsels clients on regulatory issues that arise throughout the product life cycle, including product development and approval strategy, current good manufacturing practices (cGMPs), state and federal licensing and registration, labeling, advertising and promotion, inspections, agreements pertaining to quality and regulatory issues, recall management, and regulatory enforcement actions.

Jae has extensive experience in conducting regulatory due diligence on behalf of companies seeking to acquire or invest in companies with a portfolio of regulated products. She also has experience in providing strategic regulatory advice and counseling for companies facing internal investigations, litigation, and arbitrations.

Jae has also advised multinational and start-up companies on navigating federal and state COVID-19 requirements, including FDA's Emergency Use Authorization (EUA) process and enforcement discretion policies for personal protective equipment (such as face masks, face shields, gowns and gloves) as well as hand sanitizers and other medical products.

Jae serves on the Philadelphia office's Diversity & Inclusion Committee, and is the co-manager of Cultivate, a DLA Piper blog focused on the hemp and CBD industry. She is also actively involved in the regulatory community, and serves on the Food and Drug Law Institute (FDLI)'s Cannabis Products Committee and Webinar Committee, as well as the Membership Committee of Women in Bio - Philadelphia Metro chapter.

English, Korean

Jae serves on the Young Lawyers Editorial Board of The Legal Intelligencer, the oldest law journal in the United States.

J.D., University of Notre Dame Law School; B.A., Johns Hopkins University