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Jae Kim

Jae Kim

Partner
PhiladelphiaWashington, DC
About

Jae Kim is a Partner in the Philadelphia and Washington D.C. offices of DLA Piper. Her Food and Drug Administration (FDA) practice is primarily focused on regulatory compliance, enforcement, and transactional matters. She frequently advises clients in the pharmaceutical, advanced therapeutics, device, and digital health industries.

She has extensive transactional experience as an FDA subject matter specialist and routinely leads regulatory due diligence projects on significant transactions. Jae routinely advises on the drafting and negotiation of various contracts, including supply agreements, quality agreements, and clinical trial agreements.

Jae also has deep experience in navigating complex regulatory requirements for food and beverage, cosmetics, hemp CBD, and dietary supplements as well as other products and services that are regulated by the U.S. Department of Agriculture (USDA), the Alcohol Tax and Trade Bureau (TTB) and state liquor authorities, the Drug Enforcement Administration (DEA), Centers for Medicare & Medicaid (CMS) and state clinical laboratory agencies, and the Consumer Product Safety Commission (CSPC).

Her knowledge and unique 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 when 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.

Outside the office, she is actively involved in the regulatory community, including the Food and Drug Law Institute (FDLI).

Areas of FocusHealthcareLife SciencesLitigation, Arbitration and InvestigationsRegulatory and Government AffairsFDA Regulatory
Bar admissionsDistrict of ColumbiaNew JerseyPennsylvania
CourtsUnited States District Court for the Eastern District of PennsylvaniaUnited States District Court for the District of New Jersey

EXPERIENCE

Select representative matters include:

  • Leading regulatory due diligence projects and advising on corporate transactions involving regulated products and companies, ranging from mergers and acquisitions, IPOs, and follow-on offerings.
  • Drafting commercial agreements and quality agreements for all levels of supply chain, including contract manufacturers, contract laboratories, and raw material suppliers (cGMP/ISO standards) as well as clinical trial agreements.
  • Leading multi-jurisdictional surveys on state and federal permit and registration issues (FDA, DEA, TTB, CLIA, State Board of Pharmacy, State Health Departments, State Liquor Authorities).
  • Serving as lead regulatory counsel in managing global product recall in over 40 countries.
  • Serving as regulatory counsel in 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).
  • Providing strategic guidance on FDA's premarket approval or clearance process, including assessment of applicable product classification.
  • Preparing responses and remediation plans in response to FDA Form 483 observations and Warning Letters.
  • Comprehensive review and drafting of quality system, governance, and compliance related SOPs.
  • Counseling on Sunshine Act reporting requirements and related compliance matters involving engagements between life science companies and HCPs.
  • Coordinating regulatory advice from counsel in Canada, Europe, Asia, and Latin America for clients with regulated products in multiple ex-U.S. jurisdictions.
Languages
  • Korean
Education
  • 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

Awards

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)

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Bylines

Select publications include:

Speaking Engagements

  • Select speaking engagements include:

    • Speaker, Revolutionizing clinical trials: A discussion on diversity and patient-centric approaches, At the Intersection of Science and Law Podcast, November 15, 2024
    • Moderator, Pathways Toward Competitive Intelligence (featuring FDA’s Katie Gray and NAD’s Jennifer Santos), FDLI Advertising and Promotion of Medical Products Conference, October 18, 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
    • 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

Memberships And Affiliations

  • Food and Drug Law Institute, Conference Co-Chair, Committee Member
  • Women in Bio (Philadelphia Chapter)

My latest insights

Publication

DLA Piper attorneys co-author article in The Global Trade Law Journal

6 March 2025 .1 minute read

News

DLA Piper advises Underwriters in Butterfly Network’s US$86.9 million Public Offering

11 February 2025 .2 minute read

Publication

Trump Administration’s DEI Executive Order and the impact on FDA’s DAP draft guidance: Top...

5 February 2025 .5 minute read

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Connect

Phone

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