FDA & HEALTHCARE REGULATORY | ASSOCIATE (3-7+ YRS): Our client, an AMLaw 100 firm, is seeking an FDA & Compounding Associate to advise healthcare and life sciences clients on FDA regulatory compliance, pharmaceutical compounding, drug supply chain issues, and related enforcement matters. The Associate will advise pharmaceutical manufacturers, outsourcing facilities, compounding pharmacies, healthcare providers, distributors, and other regulated entities on FDA and DEA requirements involving the development, manufacture, distribution, and promotion of healthcare products. The Associate will also handle high-profile GLP-1 and pharmaceutical matters and provide regulatory counseling in connection with litigation, government investigations, transactions, and day-to-day compliance matters.

REQUIREMENTS: Candidates must have 3-7+ years of relevant FDA regulatory, healthcare, life sciences, pharmaceutical regulatory, or related experience, with experience advising compounding pharmacies, outsourcing facilities, pharmaceutical manufacturers, healthcare providers, or other FDA-regulated entities. Candidates should have knowledge of FDA regulatory frameworks governing drugs and compounded medications, including Sections 503A and 503B, cGMP requirements, labeling, recalls, inspections, Form FDA 483 observations, Warning Letters, and other enforcement matters. Familiarity with DEA requirements, state pharmacy regulations, and healthcare compliance is preferred. Experience involving pharmaceutical compounding, drug supply chain regulation, GLP-1 matters, FDA investigations, litigation, or regulatory enforcement is a plus. Candidates must possess strong research, writing, and analytical skills and have a JD from an accredited law school with strong academic credentials.

TO APPLY: Please submit a resume and transcript in PDF format. Additionally, while not required, it is preferred to also submit a cover letter and a strong writing sample (dispositive motion or brief, 10-15 pages, demonstrating strong legal analysis and persuasive writing.