Strategic FDA Healthcare M&A Associate

White & Case LLP; New York; Hybrid; USD 310,000 - 390,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement savings

Vacation time

Job summary

White & Case LLP is seeking a mid-level associate to join the FDA Healthcare practice in New York. The role supports a regulatory partner and involves counseling on FDA-regulated products, healthcare compliance, and corporate transactions across life sciences clients.

The candidate should have strong drafting, analytical, and project-management abilities, with experience in FDA frameworks and cross-border deals.

Qualifications

• 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, with appropriate supervision, including regulatory diligence, legal research, document drafting and coordination with specialist teams.
• Strong time management skills, ability to stay calm under pressure when juggling multiple projects.

Responsibilities

• Advise on FDA, healthcare regulatory and compliance matters affecting life sciences, healthcare, technology and investor clients.
• Conduct regulatory due diligence in connection with mergers, acquisitions, divestitures, investments, joint ventures, strategic alliances and other corporate transactions involving healthcare and life sciences businesses.
• Review and analyze regulatory issues relating to FDA-regulated products, including pharmaceuticals, biologics, medical devices, diagnostics, digital health technologies, cosmetics, food and tobacco products.
• Support the drafting, review and negotiation of regulatory and quality provisions in commercial arrangements, including manufacturing and supply agreements, CDMO arrangements, distribution and commercialization agreements, quality and technical agreements, pharmacovigilance and safety data exchange agreements, licensing and collaboration agreements, co-promotion agreements and services agreements.
• Review and analyze healthcare regulatory issues, including federal and state licensure, reimbursement, Medicare and Medicaid participation, provider and physician arrangements, fraud and abuse laws, pharmacy and laboratory regulation, DEA requirements, telemedicine and healthcare privacy.
• Conduct and oversee legal research relating to FDA regulation, healthcare compliance, reimbursement, drug pricing, market access, government price reporting, privacy, artificial intelligence governance and enforcement risk.

Skills

Fluent English

Drafting

Analytical skills

Research

Organizational skills

Project management

Education

J.D. degree

Job description

White & Case LLP is seeking a mid-level associate to join the FDA Healthcare practice in New York. The role supports a regulatory partner and involves counseling on FDA-regulated products, healthcare compliance, and corporate transactions across life sciences clients.

The candidate should have strong drafting, analytical, and project-management abilities, with experience in FDA frameworks and cross-border deals.