Associate - FDA & Compounding

BakerHostetler is seeking an Associate with experience advising healthcare and life sciences clients on FDA regulatory compliance, pharmaceutical compounding, drug supply chain issues, and related enforcement matters. The candidate will handle high-profile GLP-1 and pharmaceutical-related matters, and will provide regulatory analysis and strategic counseling in connection with litigation, investigations, transactions, and day-to-day compliance issues. The ideal candidate will have experience advising pharmaceutical manufacturers, outsourcing facilities, compounding pharmacies, healthcare providers, distributors, and other regulated entities on FDA and DEA requirements affecting the development, manufacture, distribution, and promotion of healthcare products. Responsibilities FDA Regulatory Counseling 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. Compounding Pharmacy and Drug Supply Chain Matters Advise 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. Litigation and Regulatory Support 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. Assist 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. DEA and State Regulatory Compliance Advise clients on DEA registration and controlled substance compliance requirements. Counsel healthcare entities regarding state licensure, board of pharmacy requirements, and related regulatory obligations. Assist clients with audits, inspections, investigations, and compliance reviews. Transactions and Due Diligence Participate in healthcare and life sciences transactions, including mergers, acquisitions, divestitures, and investments. Conduct regulatory due diligence related to pharmaceutical, healthcare, and pharmacy operations. Identify regulatory risks and assist 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. Why BakerHostetler? Work across regulatory, compliance, and litigation matters with nationally recognized attorneys. Direct mentorship and meaningful responsibility from day one. Collegial, entrepreneurial culture that values collaboration and innovation. Competitive compensation and comprehensive benefits. Opportunities for professional growth and business development. Strong commitment to pro-bono work and community engagement. Location: This position may be in any of the following offices: Atlanta, GA; Austin, TX; Chicago, IL; Cincinnati, OH; Columbus, OH; Dallas, TX; Denver, CO; Houston, TX; New York, NY; Orange County, CA; Orlando, FL; Philadelphia, PA; San Francisco, CA; Seattle, WA; Washington, DC; or Wilmington, DE. Salary The salary offered in any location will be determined by a wide range of factors, including, but not limited to, experience level, education/training, and relevant skills. Associates also participate in a performance- and hours-based bonus program. BakerHostetler offers a comprehensive and competitive benefits program, including group health, dental and vision insurance, vacation (20 days), paid holidays (10 days), 401(k) plan, parental leave (10 weeks, not including disability, where applicable, and accrued vacation), family care program, wellness program, life and accident insurance, and short and long-term disability. For Denver, the expected annual salary range for this position is $220,000 - $260,000. For Chicago, New York, Orange County, San Francisco, Seattle, and Washington, D.C., the expected annual salary range for this position is $245,000 - $370,000. Application Submission Information Qualified Candidates – Self-Apply: Please apply via the link in the posting and attach your cover letter, resume, law school transcript, and writing sample. Search Firms If your search firm has a fully executed search firm agreement in place with BakerHostetler, please submit application materials, including an introduction, resume, law school transcript, and writing sample, to Deirdra Clement, Recruiting Manager, at [email protected] . If your search firm does not have a fully executed search firm agreement in place with BakerHostetler, please submit only blind candidate profiles to [email protected] . Applications will be accepted on an ongoing basis until the position is filled. Baker & Hostetler LLP is an Equal Opportunity Employer.