FDA Regulatory Associate - Drugs, Biologics, Medical Devices

Job Overview

A law firm seeks a mid-level associate with a minimum of 4 years of experience to join its practice in Washington, DC. The team advises life sciences companies on U.S. Food and Drug Administration (FDA) regulatory matters involving drugs, biologics, medical devices, and combination products. The role involves strategic counseling across the FDA medical product development lifecycle, from early-stage development through commercialization and post-market compliance.

Duties

• Review, interpret, and apply federal statutes, regulations, and guidance to medical product development.
• Draft legal, scientific, and technical materials supporting FDA regulatory strategy.
• Collaborate with partners on tailored FDA regulatory strategies.
• Support FDA submissions and regulatory pathways, including meetings and applications for drugs and biologics.
• Advise on GxP compliance, expedited approval pathways, and marketing exclusivity programs.
• Counsel on FDA compliance and enforcement matters.
• Assist with regulatory advocacy, FDA rulemaking, and policy developments.
• Advise on public-private R&D partnerships and strategic collaborations with federal agencies.
• Draft, review, and negotiate research, development, and commercialization agreements.

Requirements

• Strong regulatory drafting, analytical, and client-service skills.
• Experience advising on FDA regulatory matters for life sciences products.
• Ability to read, analyze, and draft legal, scientific, and technical materials accurately.

Education

• Juris Doctorate degree from an accredited law school.

Certifications

• Admitted to and in good standing with the relevant jurisdiction's bar.

Skills

• Technical degree (e.g., biochemistry, mechanical engineering) preferred.
• Exposure to adjacent legal areas (e.g., CMS coverage, intellectual property) advantageous.

Benefits

• Comprehensive benefits package.

With a longtime DC presence, this strong and reputable firm takes an active role in community and pro bono activities. Recognizing the importance of longevity, this firm goes far to preserve its relationship with its associates. What does that mean for the firm employing hundreds of lawyers in a wide variety of practice areas? It means that associates are well trained and a family atmosphere is fostered. The firm is consistently ranked as one of the top 100 firms and generally considered a great place to work.