Associate - FDA & Compounding

Responsibilities

• Advise clients on FDA regulatory requirements applicable to drugs, compounded medications, biologics, medical devices, dietary supplements, and related healthcare products.
• Counsel clients on current Good Manufacturing Practices (cGMP), quality systems, labeling, promotional review, adverse event reporting, product classification, recalls, and post-market compliance.
• Provide guidance regarding FDA inspections, Form FDA 483 observations, Warning Letters, consent decrees, and other regulatory enforcement actions.
• Analyze FDA guidance documents, regulations, and enforcement trends affecting healthcare and life sciences companies.
• Advising outsourcing facilities, compounding pharmacies, manufacturers, distributors, and healthcare providers regarding federal and state regulatory requirements.
• Counsel clients on issues involving Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
• Assist clients with regulatory issues involving compounded medications, drug shortages, supply chain compliance, inspection readiness, and quality management systems.
• Provide strategic guidance regarding evolving FDA policies affecting compounded GLP-1 and other high-demand pharmaceutical products.
• Support litigation teams in pharmaceutical, healthcare, and product-related matters involving FDA and compounding pharmacy issues.
• Conduct regulatory analysis and develop legal strategies related to GLP-1 and other pharmaceutical litigation.
• Afford assistance with government investigations involving the FDA, DEA, Department of Justice, state attorneys general, and state regulatory agencies.
• Prepare regulatory assessments, expert support materials, and submissions in connection with litigation and enforcement proceedings.
• Advising clients on DEA registration and controlled substance compliance requirements.
• Counsel healthcare entities regarding state licensure, board of pharmacy requirements, and related regulatory obligations.
• Afford assistance with audits, inspections, investigations, and compliance reviews.
• Participating in healthcare and life sciences transactions, including mergers, acquisitions, divestitures, and investments.
• Conducting regulatory due diligence related to pharmaceutical, healthcare, and pharmacy operations.
• Identifying regulatory risks and assisting clients in developing mitigation and post-closing compliance strategies.

Qualifications

• J.D. from an accredited law school with strong academic credentials.
• 3 to 7+ years of relevant experience in FDA regulatory law, healthcare law, life sciences, pharmaceutical regulation, or related areas.
• Experience advising compounding pharmacies, outsourcing facilities, pharmaceutical manufacturers, healthcare providers, or other FDA-regulated entities.
• Working knowledge of FDA regulatory frameworks governing drugs and compounded medications.
• Familiarity with DEA requirements, state pharmacy regulations, and healthcare compliance issues is preferred.
• Experience supporting litigation, investigations, or regulatory enforcement matters is a plus.
• Strong research, writing, and analytical skills.
• Ability to manage multiple matters in a fast-paced environment and work collaboratively across practice groups.

Preferred Qualifications

• Experience involving pharmaceutical compounding, 503A/503B outsourcing facilities, or drug supply chain regulation.
• Background supporting GLP-1, pharmaceutical, or healthcare product litigation.
• Prior experience with FDA inspections, Warning Letters, Form FDA 483 responses, or regulatory investigations.
• Advanced scientific, pharmacy, healthcare, or life sciences training is a plus.