Mid-Level Associate, FDA Healthcare

We are seeking a mid-level associate with FDA, healthcare regulatory, life sciences transactional, or related regulatory experience to join our FDA Healthcare practice. The role supports a partner whose practice integrates FDA-regulated product counseling, healthcare compliance, commercial contracting, corporate transactions, enforcement risk management, and cross-border strategy.

You will advise global life sciences, healthcare, technology, and investor clients on complex regulatory matters affecting drugs, biologics, medical devices, diagnostics, digital health technologies, cosmetics, food, and tobacco products. Matters also span healthcare regulatory regimes involving reimbursement, provider operations, telemedicine, pharmacy regulation, laboratory oversight, DEA compliance, and privacy.

Key responsibilities include:

• Advising on FDA, healthcare regulatory, and compliance matters for life sciences, healthcare, technology, and investor clients.
• Conducting and managing regulatory due diligence in connection with mergers, acquisitions, divestitures, investments, joint ventures, strategic alliances, and other corporate transactions.
• Reviewing and analyzing regulatory issues related to FDA-regulated products, including approval pathways, labeling, promotion, quality systems, manufacturing, and post-market requirements.
• Drafting, reviewing, and negotiating regulatory and quality provisions in commercial arrangements, including manufacturing and supply agreements, CDMO arrangements, distribution and commercialization agreements, quality and technical agreements, pharmacovigilance agreements, licensing and collaboration agreements, co-promotion agreements, and services agreements.
• Analyzing healthcare regulatory issues, including licensing, reimbursement, Medicare/Medicaid participation, provider and physician arrangements, fraud and abuse laws, pharmacy and laboratory regulation, DEA requirements, telemedicine, and privacy.
• Conducting and overseeing legal research on FDA regulation, healthcare compliance, reimbursement, drug pricing, market access, privacy, AI governance, and enforcement risk.

The ideal candidate combines strong transactional judgment with a practical understanding of the FDA and healthcare regulatory framework, excellent drafting and analytical skills, and the ability to manage multiple workstreams under demanding timelines. You should be collaborative, proactive, and client-service oriented, with experience coordinating with clients, opposing counsel, and subject-matter specialists on sophisticated domestic and cross-border transactions.

• 3–6 years of substantive experience at a leading law firm in M&A, healthcare regulatory, FDA regulatory, or life sciences transactional matters.
• Experience representing buyers, sellers, and financial sponsors in domestic and cross-border mergers, acquisitions, divestitures, and joint ventures.
• Meaningful experience with pharmaceutical, biotechnology, medical device, diagnostic, digital health, healthcare provider, pharmacy, laboratory, or other FDA-regulated businesses is strongly preferred.
• Familiarity with FDA regulatory frameworks, including product approval, clearance and authorization pathways, clinical research, labeling and promotion, quality systems, manufacturing, and post-market requirements.
• Ability to manage discrete workstreams independently, including regulatory diligence, legal research, document drafting, and coordination with specialist teams.
• Sound legal and commercial judgment, with the ability to identify issues early and propose practical, business-oriented solutions.
• Excellent drafting, analytical, research, organizational, and project-management skills.
• JD (or LLM/foreign equivalent) from an accredited law school and bar admission in the office's jurisdiction.
• Strong time management skills and the ability to remain composed under pressure.