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Jae Kim

Jae Kim


Jae Kim is a Partner in the Philadelphia and Washington D.C. offices of DLA Piper. Her FDA practice is primarily focused on regulatory compliance matters impacting clients that develop, manufacture, and distribute FDA-regulated products such as medical devices, drugs, food and beverage, cosmetics, and dietary supplements.  She also has deep experience in navigating complex regulatory requirements that apply to products and goods that are regulated by USDA, TTB, and DEA.

Jae’s knowledge and experience across various industries and sectors are invaluable for clients who are seeking to launch products that intersect with two or more product categories, especially if they need strategic advice on how to best position novel products to achieve their business goals.  She counsels companies in regulated industries on issues that arise throughout the product life cycle, from product development to postmarket compliance.  She has particular expertise with state and federal licensing and registration, advertising and promotion, agreements pertaining to quality, safety, and regulatory issues, pharmacovigilance, recall management, and government enforcement actions.

In addition to her regulatory practice, Jae has extensive transactional experience as a subject matter specialist, conducting FDA 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 regulatory advice and counseling for companies facing internal investigations, litigation, and arbitrations.

Jae is the Co-Vice Chair of AAPEX, the Firm's Asian American Pacific Islander 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 the Philadelphia Metro Chapter of Women in Bio.

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)


Speaking Engagements

  • Panelist, "Food and Dietary Supplement Consumer Litigation: Closing Regulatory Gaps?", FDLI Food and Dietary Supplement Safety and Regulation Conference, April 2024
  • Presenter, "Decoding FDA’s Proposed ACNU Rule and Unveiling Its Implications for the OTC Industry," ACI Advanced Legal, Regulatory and Compliance Forum on OTC Drugs, January 2024
  • Presenter, "Going Global with International and Trademark Law," Notre Dame Beer, Wine and Spirits Symposium, November 2023
  • Panelist, "Benefits and Risks of Social Media Advertising," FDLI Advertising and Promotion of Medical Products Conference, November 2023
  • 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)