FDA Compliance & Compounding Specialist

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

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.