FDA Associate – Regulation, Labeling & Marketing (Mid-Level)

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Venable LLP’s FDA Group seeks a mid-level associate to join its nationally recognized Food & Drug Law practice in the Washington, D.C. office.

Venable’s Food & Drug Law Group advises leading companies across the food, dietary supplement, medical device, cosmetic, and OTC drug industries as well as prescription drug companies on complex regulatory, compliance, advertising, and enforcement matters. The practice is known for its integrated approach to FDA, FTC, NAD, and state consumer protection issues, and for handling matters at the intersection of regulatory counseling, advertising substantiation, investigations, and litigation risk management.

The ideal candidate will have experience with some or all of the following:

• FDA regulatory counseling involving foods, dietary supplements, OTC drugs, cosmetics, and medical devices and prescription drugs, including product classification, labeling, and compliance strategy;
• Medical device regulatory matters, including premarket pathways, 510(k)s and 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); 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.

The successful candidate will have a minimum of three years of experience practicing in a law firm or comparable regulatory setting, with strong legal writing, research, and analytical skills. The practice seeks a candidate who is collaborative, proactive, detail-oriented, and comfortable handling matters independently while working closely with senior attorneys and clients.

Candidates must hold a Juris Doctor degree from an accredited law school and be admitted to and in good standing with the D.C. Bar (or eligible for prompt admission). Please include law school transcripts and a writing sample with submissions.

Venable LLP is an American Lawyer Global 100 law firm headquartered in Washington, DC, with offices in California, Colorado, Delaware, Florida, Illinois, Maryland, New York, and Virginia. Our lawyers and legislative advisors serve domestic and international clients in all areas of corporate and business law, complex litigation, intellectual property, regulatory matters, and government affairs. Additional information can be found at Venable.com.

The salary range for associate positions is $215,000 to $355,000. The actual salary offered will be based on a number of job-related factors including, but not limited to, years of related experience, level of education, skills, credentials and certifications, responsibilities and performance.

Venable LLP does not discriminate on the basis of race, gender, ethnicity, religion, national origin, age, disability, veteran status, or on any other basis prohibited by law. To view our inclusion and opportunity policy, please click here.

Contact:

Victoria Sievers

Senior Manager of Associate Recruiting

vksievers@venable.com

Venable LLP is an Equal Opportunity/Affirmative Action employer, committed to ensuring our workforce reflects America’s diverse population.

 

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