FDA Associate Attorney - D.C. Job at Direct Counsel, Washington DC

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  • Direct Counsel
  • Washington DC

Job Description

Job Description

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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