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

Direct Counsel; Washington (District of Columbia); Hybrid; USD 260,000 - 390,000; Full time

Benefits offered by this job

Discretionary bonus

Medical, dental and vision insurance

401(k)

Paid time off

Disability and life insurance

Flexible spending accounts

Additional voluntary benefits

Job summary

Direct Counsel, a Washington, D.C.-based AmLaw 100 firm, seeks a Life Sciences / Product Regulatory Associate (3-6 years) to join its Health Care group on a hybrid basis. The role focuses on FDA and product regulatory matters for life sciences, biotechnology, and technology clients.

The ideal candidate will have substantial regulatory experience, strong writing and research skills, and admission to a state bar, with opportunities to advise on development, approvals, and cross-border transactions

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.

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.

Skills

FDA regulatory knowledge

Legal research

Written communication

Client communication

Education

Bar admission (state)

Job description

Job DescriptionJob DescriptionLife 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 OverviewThis 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.