Jae focuses her practice on regulatory and litigation matters impacting clients in the life sciences and consumer products industries.

In her regulatory practice, Jae provides counseling and risk management advice to clients on state and federal regulatory matters to help them balance their regulatory responsibilities with their business needs. Jae has assisted clients with a number of complex regulatory matters, such as:

  • advising on product recall management and FDA's adverse event reporting requirements;
  • counseling on state and federal permit and registration issues (FDA, DEA, TTB, CLIA, State Board of Pharmacy);
  • evaluating labeling and marketing claims on foods and medical products based on FDA and FTC requirements;
  • preparing and reviewing company policies relating to quality and regulatory compliance
  • drafting quality agreements involving contract manufacturers and raw material suppliers (cGMP/ISO);
  • strategic guidance on FDA's premarket approval or clearance process
  • preparing responses to FDA Form 483 observations;
  • coordinating regulatory advice from counsel in Canada, Europe, Asia, and Latin America for clients with regulated products in multiple ex-U.S. jurisdictions; and
  • conducting FDA/DEA/USDA regulatory due diligence in transactions involving regulated medical and consumer products.

Her medical and consumer products practice encompasses a wide range of products, including medical devices, digital health technology, drugs, foods and beverages, dietary supplements, alcohol, tobacco, cosmetics, clinical laboratories, and raw material suppliers.

In addition to her broad regulatory practice, she has experience defending large multinational companies in product liability and commercial litigation.

Jae serves on the Philadelphia office's Hiring Committee and Diversity & Inclusion Committee.