Job Description

Job Description

FDA Associate – Health & Life Sciences Practice Group
Location: Washington, D.C.
Compensation: Cravath Scale

Overview:
Direct Counsel is representing an Am Law 100 firm seeking a highly qualified FDA Associate Attorney to join its Health & Life Sciences Practice Group in Washington, D.C. The ideal candidate will have 4–5 years of experience focused on drug and medical device regulatory compliance , with a particular emphasis on current good manufacturing practice (CGMP) matters.

This nationally ranked FDA practice advises clients across the full spectrum of FDA-regulated products, including pharmaceuticals, biologics, medical devices, digital health technologies, food, and cosmetics. The firm offers the opportunity to work on complex, high-impact matters with leading life sciences companies at all stages of growth.

Key Responsibilities:

• Advise clients on FDA regulatory issues related to drugs and devices, particularly CGMP compliance.

• Conduct legal research and provide analysis on a wide range of FDA compliance and enforcement topics.

• Draft and review regulatory filings, compliance documentation, quality policies, and commercial agreements.

• Collaborate with clients and cross-functional teams to develop and implement effective regulatory strategies.

• Represent clients in FDA inspections, investigations, warning letters, and other enforcement actions.

• Stay current on FDA regulations, policy updates, and industry developments.

Qualifications:

• 4–5 years of relevant experience in FDA regulatory compliance, preferably at a law firm or in-house.

• Deep understanding of FDA regulations, particularly CGMP standards.

• Industry experience advising biopharma or device companies or a scientific background in analytical chemistry, chemical engineering, or microbiology is strongly preferred.

• Prior experience at the Food and Drug Administration (FDA) is a plus.

• Outstanding analytical, communication, and writing skills.

• Strong academic credentials.

• Admission to the D.C. Bar or eligibility for admission via reciprocity or UBE score transfer.

Compensation:
This position offers a Cravath Scale salary and bonus structure, aligned with class year and experience.

Application Process:
Please apply through the firm's web portal. For questions regarding this opportunity, contact: