FDA Regulatory Attorney

About This Role

Advise clients on FDA regulatory compliance and strategy, supporting product development and lifecycle management for FDA-regulated products. This role involves working closely with experienced partners on complex FDA-related matters within a U.S. law firm specializing in healthcare and life sciences.

Responsibilities

• Advising clients on FDA regulatory compliance and strategy
• Supporting product development, approvals, and lifecycle management for FDA-regulated products
• Assisting with FDA enforcement actions, investigations, and regulatory risk management
• Drafting and reviewing regulatory submissions, guidance responses, and compliance documentation
• Working collaboratively with partners and clients to deliver practical regulatory solutions

Requirements

• 4+ years of FDA regulatory experience gained within a law firm
• Strong working knowledge of FDA regulations impacting drugs, biologics, medical devices, and/or food and dietary supplements
• Experience advising clients on regulatory compliance and FDA interactions
• Ability to manage matters independently with appropriate partner supervision
• Strong drafting, analytical, and communication skills

Qualifications

• A minimum of 4+ years of FDA regulatory experience gained within a law firm

Nice to Have

• Washington, D.C. bar admission preferred

Benefits

Certifications