FDA & Compounding Associate

Baker & Hostetler LLP; Orlando (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

Baker & Hostetler LLP seeks an experienced FDA/regulatory attorney to advise healthcare and life sciences clients on regulatory compliance matters, investigations, and transactions. Ideal candidates have a track record advising pharmaceutical manufacturers, outsourcing facilities, compounding pharmacies, or other FDA-regulated entities, with exposure to GLP-1 matters and drug supply chain issues.

Strong knowledge of FDA inspections and enforcement actions is a plus.

Qualifications

• Experience advising FDA-regulated entities on drugs and regulated products.
• Experience with GLP-1 litigation or healthcare product litigation preferred.
• Familiarity with FDA inspections or enforcement actions is a plus.
• Advanced scientific, pharmacy, healthcare, or life sciences training is a plus.

Skills

FDA regulatory experience

Pharmaceutical industry knowledge

Regulatory due diligence

Litigation support

Job description

Overview

• Advises healthcare and life sciences clients on FDA regulatory compliance, pharmaceutical compounding, drug supply chain issues, and related enforcement matters, handling high-profile GLP-1 and pharmaceutical-related matters.
• Provides regulatory analysis and strategic counseling for litigation, investigations, transactions, and day-to-day compliance issues, covering areas such as current Good Manufacturing Practices (cGMP), quality systems, labeling, promotional review, adverse event reporting, product classification, recalls, and post-market compliance.
• Counsels on FDA regulatory requirements for drugs, compounded medications, biologics, medical devices, dietary supplements, and related healthcare products, including guidance on FDA inspections, Form FDA 483 observations, Warning Letters, consent decrees, and other enforcement actions.
• Advises outsourcing facilities, compounding pharmacies, manufacturers, distributors, and healthcare providers on federal and state regulatory requirements, including Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, with a focus on compounded medications, drug shortages, supply chain compliance, inspection readiness, and quality management systems.
• Supports litigation and government investigations involving the FDA, DEA, Department of Justice, state attorneys general, and state regulatory agencies, conducting regulatory analysis and developing legal strategies for pharmaceutical and product-related matters, particularly GLP-1 litigation.
• Advises clients on DEA registration and controlled substance compliance, state licensure, board of pharmacy requirements, and related regulatory obligations, assisting with audits, inspections, investigations, and compliance reviews.
• Participates in healthcare and life sciences transactions, including mergers, acquisitions, divestitures, and investments, by conducting regulatory due diligence, identifying risks, and developing mitigation and post-closing compliance strategies.
• Requires experience advising pharmaceutical manufacturers, outsourcing facilities, compounding pharmacies, healthcare providers, distributors, or other FDA-regulated entities, along with a working knowledge of FDA regulatory frameworks governing drugs and compounded medications.
• Preferred qualifications include experience with pharmaceutical compounding, 503A/503B outsourcing facilities, drug supply chain regulation, supporting GLP-1/pharmaceutical/healthcare product litigation, and prior experience with FDA inspections or regulatory investigations; advanced scientific, pharmacy, healthcare, or life sciences training is a plus.