FDA & Compounding Associate

Baker & Hostetler LLP; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Job summary

Baker & Hostetler LLP in Washington, DC seeks a regulatory professional to counsel healthcare and life sciences clients on FDA requirements for drugs, compounded medications, biologics, devices, and dietary supplements. The role emphasizes cGMP, labeling, promotional review, and post-market compliance.

The attorney will support litigation and investigations involving the FDA, DEA, and state regulators, including responses to inspections and enforcement actions.

Qualifications

• Regulatory analysis and strategic counseling for high-profile GLP-1 and pharmaceutical-related matters across litigation, investigations, transactions, and day-to-day compliance issues.
• Prior experience with FDA inspections, Warning Letters, Form FDA 483 responses, or regulatory investigations is a preferred qualification.

Responsibilities

• Advise on FDA requirements for drugs, compounded medications, biologics, medical devices, and dietary supplements, covering cGMP, labeling, and post-market compliance.
• Counsel clients through FDA inspections and enforcement actions, analyzing guidance and enforcement trends.
• Assist with FDA-related litigation, investigations, and regulatory due diligence in healthcare and life sciences transactions.

Job description

Overview

• The role provides FDA regulatory compliance, pharmaceutical compounding, drug supply chain, and related enforcement advice to healthcare and life sciences clients, including pharmaceutical manufacturers, outsourcing facilities, compounding pharmacies, healthcare providers, and distributors.
• Work involves regulatory analysis and strategic counseling for high-profile GLP-1 and pharmaceutical-related matters across litigation, investigations, transactions, and day-to-day compliance issues.
• Responsibilities include advising on FDA requirements for drugs, compounded medications, biologics, medical devices, and dietary supplements, covering cGMP, quality systems, labeling, promotional review, adverse event reporting, and post-market compliance.
• Counsels clients through FDA inspections (Form FDA 483, Warning Letters, consent decrees), analyzing guidance, regulations, and enforcement trends.
• Provides specific advice on Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, drug shortages, supply chain compliance, and evolving FDA policies for compounded GLP-1 and other high-demand products.
• Supports litigation teams and government investigations involving the FDA, DEA, Department of Justice, and state regulatory agencies, developing legal strategies and preparing expert support materials.
• Advises on DEA registration, controlled substance compliance, state licensure, and board of pharmacy requirements, assisting with audits and compliance reviews.
• Participates in healthcare and life sciences transactions (mergers, acquisitions, divestitures, investments), conducting regulatory due diligence and developing risk mitigation and post-closing compliance strategies.
• A preferred qualification is 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.