Mid-Level FDA Healthcare Associate

White & Case LLP; New York; Hybrid; USD 180,000 - 230,000; Full time

Job summary

White & Case LLP seeks a regulatory practitioner to support a partner in FDA-regulated product counseling and healthcare compliance. You will participate in commercial contracting, cross-border transactions, and enforcement risk management within the life sciences and healthcare sectors.

The role requires experience with pharmaceutical, biotechnology, medical device, or digital health businesses and a solid grasp of FDA pathways, labeling, and post‑market requirements.

Qualifications

• Requires strong transactional judgment.
• Experience representing buyers, sellers, and financial sponsors in domestic and cross-border M&A.
• Meaningful experience with pharma/biotech/medical devices/diagnostics/digital health.
• Familiarity with FDA regulatory frameworks and post-market requirements.

Responsibilities

• Supports a regulatory partner across FDA-regulated product counseling, healthcare compliance, and commercial contracting.
• Advises on complex regulatory matters affecting drugs, devices, cosmetics, and dietary products.
• Conducts regulatory due diligence for corporate transactions involving healthcare and life sciences.
• Drafts and negotiates regulatory and quality provisions in commercial agreements.

Skills

Regulatory compliance

FDA knowledge

Due diligence

Cross-border transactions

Healthcare regulatory

Job description

Overview

• Supports a regulatory partner whose practice integrates FDA-regulated product counseling, healthcare compliance, commercial contracting, corporate transactions, enforcement risk management, and cross-border strategy.
• Advises 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.
• Addresses healthcare regulatory regimes including reimbursement, provider operations, telemedicine, pharmacy regulation, laboratory oversight, DEA compliance, and privacy.
• Conducts and manages regulatory due diligence for corporate transactions (mergers, acquisitions, divestitures, investments, joint ventures, strategic alliances) involving healthcare and life sciences businesses.
• Supports the drafting, review, and negotiation of regulatory and quality provisions in commercial arrangements, including manufacturing and supply, CDMO, distribution, commercialization, quality/technical, pharmacovigilance, safety data exchange, licensing, collaboration, co-promotion, and services agreements.
• Conducts and oversees legal research on FDA regulation, healthcare compliance, reimbursement, drug pricing, market access, government price reporting, privacy, artificial intelligence governance, and enforcement risk.
• Requires strong transactional judgment combined with a practical understanding of FDA and healthcare regulatory frameworks.
• Requires 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, or laboratory businesses is strongly preferred.
• Familiarity with FDA regulatory frameworks, including product approval/clearance/authorization pathways, clinical research, labeling/promotion, quality systems, manufacturing, and post-market requirements.