Associate, FDA Healthcare

White & Case LLP•New York, NY

39d•$310,000 - $390,000•Onsite

About The Position

Our Mergers & Acquisitions (M&A) Practice is globally recognized as a top-tier leader in both public and private M&A transactions. We deliver unparalleled legal services for complex corporate deals, offering strategic planning, due diligence, negotiation, and execution of mergers, acquisitions, divestitures, joint ventures, and other business combinations. Serving a diverse clientele, including multinational corporations, private equity firms and banks, our team ensures regulatory compliance, manages risk, and structures transactions for optimal outcomes. By combining extensive legal expertise with deep market insight, we help clients navigate high-stakes transactions, fostering growth and creating value, solidifying our reputation as one of the premier M&A practices worldwide. Position Summary We are seeking a mid-level associate with FDA, healthcare regulatory, life sciences transactional or related regulatory experience to join our FDA Healthcare practice in the New York office. The associate will support a regulatory partner whose practice integrates FDA-regulated product counseling, healthcare compliance, commercial contracting, corporate transactions, enforcement risk management and cross-border strategy. The role will involve advising 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 will also span healthcare regulatory regimes involving reimbursement, provider operations, telemedicine, pharmacy regulation, laboratory oversight, DEA compliance and privacy. The ideal candidate will combine strong transactional judgment with a practical understanding of the FDA and healthcare regulatory framework. Candidates should have excellent drafting, analytical, research, organizational, and project-management skills, as well as the ability to communicate complex regulatory considerations clearly and commercially to clients and deal teams. The role requires composure, attention to detail and an ability to manage multiple workstreams under demanding timelines. The successful candidate will be collaborative, proactive and self-motivated, with a strong commitment to client service and high-quality work product. Regular work on sophisticated domestic and cross-border transactions will require the ability to coordinate effectively with clients, opposing counsel, subject-matter specialists and other stakeholders.

Requirements

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
Exercises sound legal and commercial judgment; identifies issues early and proposes practical, business-oriented solutions
Demonstrates intellectual curiosity and creative thinking when addressing complex legal and structural issues
Anticipates client needs and maintains a service-oriented mindset consistent with our client expectations
Communicates clearly and professionally with clients, opposing counsel, and internal stakeholders
Contributes to a collaborative, high-performing team culture
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
Proactive, resourceful, takes initiative and a self-starter
Fluency in English

Responsibilities

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.