FDA Associate

The FDA Group is a nationally recognized Food & Drug Law practice based in Washington, D.C. The team advises leading companies across the food, dietary supplement, medical device, cosmetic, OTC drug, and prescription drug industries. The practice is known for its integrated approach to FDA, FTC, NAD, and state consumer protection issues, handling matters at the intersection of regulatory counseling, advertising substantiation, investigations, and litigation risk management.

This is a midlevel associate position in the Washington, D.C. office. The role involves working on complex regulatory, compliance, advertising, and enforcement matters for clients.

• Handle legal matters independently.
• Collaborate closely with senior attorneys.
• Work directly with clients.

• Minimum of three years of experience practicing in a law firm or comparable regulatory setting.
• Strong legal writing, research, and analytical skills.
• Juris Doctor degree from an accredited law school.
• Admitted to and in good standing with the D.C. Bar (or eligible for prompt admission).
• Experience with some or all of the following:- FDA regulatory counseling involving foods, dietary supplements, OTC drugs, cosmetics, medical devices, and prescription drugs, including product classification, labeling, and compliance strategy.
• Medical device regulatory matters, including premarket pathways, 510(k)s, labeling and promotional compliance, post-market obligations, inspections, and enforcement risk.
• FTC advertising and marketing compliance, including claims substantiation, labeling review, and promotional risk assessments.
• Civil investigative demands (CIDs) and access letters.
• National Advertising Division (NAD) proceedings, defense and challenges, and compliance counseling.
• Advertising claims substantiation, including ingredient and product assessments.
• Class action and pre-litigation consumer protection matters, including CLRA demand letters, litigation risk assessments, and coordination with litigation teams.
• State AG and DA inquiries, subpoenas, and investigations.
• FDA inspections, warning letters, recalls, and enforcement actions.
• Import/export issues and supply chain compliance.
• Ingredient reviews, including NDIs, and regulatory status assessments.
• California Proposition 65 compliance.
• Good manufacturing practice (GMP) regulations.
• Prescription drug labeling and promotional compliance, including FDA advertising and promotion considerations.