Associate, District of Columbia · AmLaw Global 100

This firm's health care practice seeks a regulatory specialist to advise life sciences and biotechnology companies on FDA compliance, product development, and commercialization strategy. The role combines regulatory counsel, transactional due diligence, and cross-border compliance support.

The work:

• Advise on FDA regulatory pathways, approval processes, and post-market compliance
• Conduct regulatory due diligence for M&A transactions and strategic partnerships
• Develop multi-jurisdictional compliance programs across US, Europe, and Asia
• Monitor and analyze regulatory developments; prepare strategic guidance for clients
• Support licensing agreements and cross-border transactions involving life sciences companies

What they're looking for:

• 3-6 years of law firm or in-house experience in life sciences product regulatory law
• Substantive understanding of FDA processes and biotech product development
• Ability to work effectively on complex matters in fast-paced environments
• Strong research, writing, and analytical skills
• Bar admission
• Preferred: experience with cell/gene therapy, CMS reimbursement, or Japanese/Mandarin fluency