Legal Counsel, FDA Regulations

FDA Regulatory Associate – Health & Life Sciences Practice | Washington, DC

Our client, a nationally recognized law firm with a strong commitment to inclusivity, innovation, and well-being, is seeking an FDA Regulatory Associate with 4–5 years of experience to join its Health & Life Sciences Practice Group in Washington, DC. This is an outstanding opportunity for a motivated attorney to advise a diverse range of clients across the FDA-regulated product ecosystem, including pharmaceuticals, medical devices, biologics, health technologies, food, and cosmetics.

Key Responsibilities:

• Advise clients on FDA regulatory matters, with a focus on drug and medical device compliance, including current good manufacturing practices (CGMP)
• Draft and review regulatory submissions, compliance policies, internal procedures, and contracts
• Provide legal guidance during FDA inspections, investigations, and enforcement actions
• Conduct legal research and analysis on FDA laws, regulations, and enforcement trends
• Collaborate with clients and internal teams to develop regulatory strategies that support business objectives
• Stay current on evolving FDA regulations, guidance documents, and industry developments

Ideal Candidate Profile:

• 4–5 years of experience in FDA regulatory compliance, ideally from a law firm or in-house setting
• Demonstrated knowledge of CGMP and FDA regulatory frameworks related to drug and device development
• Scientific background in analytical chemistry, chemical engineering, or microbiology (strongly preferred)
• Prior experience at the Food and Drug Administration (FDA) is a plus
• Exceptional research, analytical, and problem-solving skills
• Outstanding written and verbal communication abilities
• Strong academic credentials
• Ability to thrive in a fast-paced, collaborative environment
• Active bar membership in the District of Columbia, or eligibility to waive in through reciprocity or UBE transfer

Why Join?

• Award-Winning Culture: Recognized by Vault, Chambers Associate, and the Human Rights Campaign for top marks in diversity, associate satisfaction, and career development
• Innovative Compensation Model: Associates are rewarded for performance and initiative—67% earned above the Cravath scale in 2024
• Well-Being Focused: The firm offers billable credit for wellness, free access to the Peloton app, Lyra mental health services, and generous paid leave benefits
• Career Development: Comprehensive coaching, mentorship, and business development support, including firm-sponsored coaching for associates achieving 250 BD hours annually
• Community Engagement: Up to 8 hours of billable time available for volunteer service

To Apply:

Please submit your:

• Resume
• Cover letter
• Law school transcript

This is an exciting opportunity to join a market-leading FDA regulatory practice within a firm that values excellence, inclusion, innovation, and work-life balance. If you’re ready to elevate your legal career in a supportive and fast-paced environment, we encourage you to apply.