Health Care Life Sciences Regulatory Associate (Mid-Level) DC

Job Description

Job Description

Life Sciences / Product Regulatory Associate – Washington, D.C.

Direct Counsel represents an AmLaw 100 firm seeking a 3rd–6th year Associate to join its Life Sciences / Product Regulatory practice within the Health Care group.

Location: Washington, D.C.
Work Arrangement: Hybrid

Position Overview

This is an excellent opportunity for a regulatory attorney to advise life sciences, biotechnology, and technology companies on sophisticated FDA and product regulatory matters, as well as complex transactions and cross-border regulatory strategies.

Key Responsibilities

• Advise life sciences and technology clients on FDA and product regulatory matters
• Counsel clients on product development, approval pathways, commercialization, and lifecycle management
• Support regulatory aspects of M&A, strategic alliances, and licensing transactions
• Conduct regulatory due diligence for life sciences and advanced technology transactions
• Develop and implement compliance strategies across multiple jurisdictions
• Monitor regulatory and legislative developments and provide actionable client guidance

Qualifications

• 3–6 years of relevant experience in a law firm, government agency, or in-house legal department
• Substantive experience in life sciences product regulatory law
• Familiarity with FDA regulatory pathways and compliance requirements
• Strong research, writing, analytical, and communication skills
• Ability to manage complex matters in a fast-paced, client-focused environment
• Admission to at least one state bar required

Preferred Experience

• Cell and gene therapy, immuno-oncology, or advanced biotechnology
• CMS reimbursement and pricing matters
• Cross-border regulatory matters
• National security and trade policies affecting life sciences or semiconductor industries
• Professional fluency in Japanese or Mandarin is a strong plus

Compensation & Benefits

$260,000–$390,000 per year , depending on experience and other factors.

Competitive compensation and excellent benefits , including potential discretionary bonus, medical, dental and vision insurance, 401(k), paid time off, disability and life insurance, flexible spending accounts, and additional voluntary benefits.

Hybrid | Washington, D.C.