What are the responsibilities and job description for the Health Care Life Sciences Regulatory Associate (Mid-Level) – DC position at Direct Counsel?
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.
Salary : $260,000 - $390,000