Associate, FDA Healthcare

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

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.

Duties and Accountabilities

• 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.

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
• 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

Locations and Compensation

• Offices: New York, Boston, Chicago or Washington, DC
• Salary Range: US$310,000- 390,000

This role reports to

Partner

Equal Opportunities

White & Case is an Equal Employment Opportunity (EEO) employer and is committed to creating a fair workplace. It is our Firm's policy to recruit, employ, train, compensate and promote without regard to race, color, religion, creed, national origin, age, gender, sexual orientation, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable law.

Applicants who are interested in applying for a position and require an accommodation during the process should contact [e-mail].

Benefits at White & Case

• Medical insurance
• Dental insurance
• Vision insurance
• Life coverage
• Disability coverage
• 401(k) retirement savings
• Vacation time
• Leave programs (including parental leave)
• Performance bonus eligibility for exempt roles

The Firm may modify and amend any job description at any time in its sole discretion. Nothing herein creates a contract of employment or otherwise modifies the at-will nature of employment.

The above is only a general description of the essential duties associated with this position and does not represent an exhaustive or comprehensive list of all duties.

Note to Recruitment Agencies

Our internal Recruitment team manages all aspects of lateral hiring. All agencies must have signed terms of business-specific to the relevant office-before submitting any candidates. CVs or applications sent directly to White & Case partners or employees will also not be considered formal introductions. If you have questions, please contact the relevant Recruitment team. We work with our preferred suppliers when engaging agencies.