Job Description
Job Description: FDA Associate (4th–5th Year)
Location: Washington, D.C.
An AmLaw 100 firm is seeking a mid-level FDA Associate (4–5 years) to join its nationally ranked Health & Life Sciences Practice in the Washington, D.C. office. This role offers the opportunity to work with a market-leading team that counsels top clients across the full spectrum of FDA-regulated products , including drugs, medical devices, biologics, cosmetics, and food .
This is a great fit for a motivated attorney with deep knowledge of FDA regulatory compliance , particularly CGMP (current good manufacturing practice) issues. Candidates with industry experience or a scientific background in analytical chemistry, chemical engineering, or microbiology are strongly encouraged to apply.
Key Responsibilities:
Advise clients on FDA compliance and enforcement matters, with a focus on CGMP and regulatory strategy
Draft and review regulatory submissions, standard operating procedures, and internal compliance policies
Represent clients in FDA inspections, audits, and enforcement actions
Analyze and interpret FDA statutes, regulations, and guidance documents
Collaborate with interdisciplinary teams including corporate, IP, and litigation attorneys
Monitor regulatory developments and advise clients proactively on risk and compliance strategies
Candidate Requirements:
4–5 years of relevant experience in FDA regulatory compliance at a law firm, in-house legal department, or FDA
Deep understanding of CGMP requirements and regulatory issues for drugs and medical devices
Scientific or technical background (e.g., analytical chemistry, chemical engineering, microbiology) strongly preferred
Experience working with or at the Food and Drug Administration (FDA) is a plus
Outstanding academic credentials from an ABA-accredited law school
Excellent writing, communication, and problem-solving skills
Must be barred in the District of Columbia or eligible for admission via reciprocity or UBE score transfer
Compensation:
This position offers Cravath-scale compensation , including market-leading base salary and annual bonuses.
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