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Jae Kim

Jae Kim


Jae Kim is a senior associate in the FDA Regulatory Group, and advises clients in the medical device, pharmaceutical, food and beverage, hemp and CBD, and consumer products industries on regulatory compliance matters.

She counsels companies in regulated industries 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.

In addition to her regulatory practice, Jae has extensive experience as a subject matter specialist, conducting 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 is a member of the Firmwide Associates Committee and serves as the Co-Vice Chair of AAPEX, the Firm's AAPI Resource Group. Outside the office, she is actively involved in the regulatory community and holds committee positions with the Food and Drug Law Institute (FDLI) and Women in Bio – Philadelphia Metro Chapter.

Bar admissionsDistrict of ColumbiaNew JerseyPennsylvania
CourtsUnited States District Court for the Eastern District of PennsylvaniaUnited States District Court for the District of New Jersey


Jae's experience includes:

  • Serving as regulatory counsel in several internal investigations for biotechnology companies involving allegations of GxP violations;
  • Serving as lead regulatory counsel for leading global insurance organization in an arbitration involving FDA representations and warranties;
  • Serving as lead regulatory counsel for medical device contract manufacturer to successfully resolve customer audit findings through comprehensive GMP remediation plan;
  • Performing legal evaluation and risk assessment of labeling and promotional materials based on FDA and FTC requirements (for medical devices, pharmaceutical products, food and beverage, dietary supplements, cosmetics);
  • Drafting quality agreements for all levels of supply chain, including contract manufacturers, contract laboratories, and raw material suppliers (cGMP/ISO standards);
  • Drafting clinical trial agreements;
  • Providing strategic guidance on FDA's premarket approval or clearance process, including assessment of applicable product classification;
  • Advising clients on FDA's adverse event reporting requirements;
  • Counseling on state and federal permit and registration issues (FDA, DEA, TTB, CLIA, State Board of Pharmacy, State Health Departments);
  • Preparing responses to FDA Form 483 observations;
  • Comprehensive review and drafting of quality system, governance, and compliance related SOPs;
  • Counseling on Sunshine Act reporting requirements;
  • Coordinating regulatory advice from counsel in Canada, Europe, Asia, and Latin America for clients with regulated products in multiple ex-U.S. jurisdictions; and
  • Extensive experience in conducting regulatory due diligence on behalf of clients in transactions involving regulated products.
  • Korean
  • J.D., University of Notre Dame Law School
    • Editor in Chief, Notre Dame Journal of Law, Ethics & Public Policy
    • Notre Dame Moot Court Board
  • B.A., Johns Hopkins University


  • The Legal 500 United States
    Recommended, Product Liability, Mass Tort and Class Action: Consumer Products (including Tobacco) (2022)
    Recommended, Product Liability, Mass Tort and Class Action: Pharmaceuticals and Medical Devices - Defense (2022)



  • Moderator, "The Intersection Between FDA and Other Government Agencies," Food and Drug Law Institute (FDLI), June 13, 2023
  • Panelist, "Best Practices for Implementing a Labeling Change," Advertising and Promotion Regulatory Affairs Conference – Arlington, Virginia, February 23, 2023
  • Panelist, "Promoting Diversity and Inclusion through Advertising and Promotion," Food and Drug Law Institute Conference, October 2022
  • Panelist, "Cannabis Legislation Proposals, State-Level Legalization, and Regulatory Activity," Food and Drug Law Institute Conference, May 2022
  • Presenter, "510(k)'s versus PMA's: Impacts in Defending Cases Involving Implanted Medical Devices," DRI Drug and Medical Device Litigation Seminar, May 2020

Memberships And Affiliations

  • Leadership Council on Legal Diversity (LCLD), 2022 Pathfinder
  • Philadelphia Diversity Law Group (PDLG) Alumni Association
  • Women in Bio (Philadelphia Chapter), Membership Co-Vice Chair
  • Food and Drug Law Institute, Committee Member



+1 215 656 3352
(Work, Philadelphia)
+1 202 799 4000
(Work, Washington, DC)