Healthcare Associate – FDA & Life Sciences regulatory

Location: New York, Washington D.C., Chicago and Charlotte

Salary: $295,000 - $370,000

The New York office of a prominent Am Law 100 firm seeks an Associate Attorney to join its Healthcare Practice.

This nationally recognized team embraces diverse perspectives, provides impeccable service, and delivers innovative, business-minded healthcare solutions. As part of this leading law firm, your healthcare expertise will contribute to a robust foundation and expanding services in life sciences regulatory work and other key areas across the healthcare industry. The team and its individual lawyers are consistently ranked among the top legal providers and their insights are regularly sought by industry journals and major news organizations. This position is part of a national search with a focus on New York, Washington D.C., Chicago, and Charlotte.

The Associate will contribute to a diverse range of healthcare matters, serving clients from all critical sectors of the healthcare and life sciences industry, including: Private equity funds, Academic medical centers, Pharmaceutical and device companies, Dietary supplement manufacturers, Cosmetics companies, Contract research organizations (CROs), Cannabis multistate operators, Imaging facilities, Pre-clinical and clinical laboratories, Site management organizations (SMOs), Clinical trial networks, Physician-hospital organizations (PHOs), Pharmacies, Specialty medical clinics, as well as, other related distributors, suppliers, third-party logistics providers, and trade associations.

Requirements:

• J.D. degree and admission to the New York Bar (other state bars may be considered depending on location).
• 3-5 years of relevant experience in a top 100 law firm setting.
• 3-5 years of FDA regulatory compliance experience, including preclinical through commercial product development, product approvals, labeling, inspections, manufacturing, recalls, 483 responses, adverse event management, contract drug and device manufacturing, and quality agreements.
• Experience with life science diligence of acquisitions, DSHEA, the Food, Drug, and Cosmetic Act, and the Federal Trade Commission Act, including advertising and promotional practices for devices, drugs, dietary supplements, biologics, and cosmetics.
• Experience servicing clients in the life sciences industry with a strong understanding of the client landscape.

Preferred Qualifications:

• Experience with state Boards of Pharmacy regulations and licensure, FDA market denial orders, credit agreements, IPOs in life sciences, cannabis licensure and regulation, and telemedicine-based drug delivery.
• Experience advising in litigation-adjacent roles in life sciences.
• Prior employment in a sophisticated law firm environment, healthcare experience, employment at the FDA or a life sciences company, and life sciences coursework.
• Compensation:

The firm offers a competitive benefits package, hours-based and merit bonus opportunities, billable hour credit for pro bono work and hybrid remote work options.