Associate, FDA Healthcare at White & Case

The role

White & Case seeks a mid-level Associate for its FDA Healthcare practice in New York. This role is for an attorney with 3-6 years of experience in FDA, healthcare regulatory, or life sciences transactional matters, focusing on advising clients on complex regulatory issues.

What you'll do

Advise on FDA, healthcare regulatory and compliance matters affecting life sciences, healthcare, technology and investor clients
Conduct and manage 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
Help ensure that clients’ commercial objectives and regulatory interests are appropriately identified, represented and protected throughout the transaction lifecycle

What we're looking for

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

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

Exercises sound legal and commercial judgment; identifies issues early and proposes practical, business-oriented solutions

Communicates clearly and professionally with clients, opposing counsel, and internal stakeholders

Strong academic record and excellent legal drafting and analytical skills

A Juris Doctor (JD) degree (LLM or foreign equivalent) from an accredited law school

Admitted to the bar in the office’s jurisdiction and in good standing

Strong time management skills, ability to stay calm under pressure when juggling multiple projects

Meaningful experience with pharmaceutical, biotechnology, medical device, diagnostic, digital health, healthcare provider, pharmacy, laboratory or other FDA-regulated businesses is strongly preferred· nice to have

Demonstrates intellectual curiosity and creative thinking when addressing complex legal and structural issues· nice to have

Anticipates client needs and maintains a service-oriented mindset consistent with our client expectations· nice to have

Contributes to a collaborative, high-performing team culture· nice to have

Proactive, resourceful, takes initiative and a self-starter· nice to have

Associate, FDA Healthcare

The role

What you'll do

What we're looking for

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