Senior Counsel, Regulatory – Pharmacy Services

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Act as the primary legal advisor for Board of Pharmacy complaints, inspections, citations, and enforcement actions.

• Review and authorize written regulatory responses.

• Provide guidance on escalation risks, remediation strategies, and engagement with regulators.

• Collaborate with Compliance and Pharmacy Practice to identify trends and implement preventive measures.

• Offer advice on pharmacy licensure and operational compliance across various jurisdictions.

• Interpret and apply complex, evolving pharmacy laws.

• Assist with audits, inspections, and regulatory inquiries.

• Counsel on regulations related to 340B models, biosimilars, and REMS.

• Lead the legal evaluation of shared services and centralized pharmacy models.

• Assess regulatory permissibility and risk on a state-by-state basis.

• Support regulatory advocacy efforts and responses to rulemaking.

• Provide legal interpretation of new and pending pharmacy-related legislation.

• Convert regulatory requirements into actionable operational guidance.

• Represent Legal on pharmacy and compliance committees.

• Work collaboratively with Product, Operations, and Government Affairs teams.

• Offer decision support across Legal, Compliance, and Pharmacy Practice departments.

⛳️ Requirements

• Juris Doctor (J.D.) degree from an accredited law school and active membership in the bar.

• Minimum of 8 years of relevant legal experience (including law firm, in-house, or government roles).

• Extensive experience in healthcare and/or pharmacy regulatory law, particularly in advising on regulatory enforcement issues (e.g., inspections, complaints, or investigations).

• Strong working knowledge of the pharmaceutical supply chain, particularly in pharmacy operations, distribution, or similar models is preferred.

• Experience with Board of Pharmacy issues, 340B, REMS, or similar regulatory frameworks is preferred; a Pharm.D. or other clinical/pharmacy background is beneficial.

• Excellent analytical, written, and verbal communication skills, with the capacity to translate complex legal requirements into practical guidance.

• Demonstrated ability to influence cross-functional stakeholders and provide practical, business-focused legal advice.

• Capable of managing multiple priorities in a dynamic environment with sound judgment and attention to detail.

• Self-motivated individual with the ability to independently prioritize tasks and drive initiatives forward.

🏝️ Benefits

• Medical, vision, dental, and well-being and behavioral health programs.

• 401(k) retirement plan.

• Company-paid life insurance.

• Tuition reimbursement program.

• A minimum of 18 days of paid time off annually.

• Paid holidays.