Healthcare Regulatory Counsel (Pharma)

Overview

A legal position is available for a Healthcare Regulatory Counsel specializing in the pharmaceutical sector. This role involves providing legal and regulatory guidance to pharmaceutical organizations on patient access and support programs, including copay assistance initiatives, HUB services, reimbursement support, and patient services for specialty and biologic therapies. A key focus will be on managing Fraud & Abuse risk within pharmaceutical patient support programs and ensuring compliance with federal and state healthcare regulations.

Responsibilities

• Advise pharmaceutical clients on legal and regulatory issues related to patient support and access programs.
• Provide guidance on Fraud & Abuse laws such as the Anti-Kickback Statute and False Claims Act.
• Support the development, review, and oversight of copay programs, HUB services, and reimbursement support initiatives.
• Review program structures, vendor arrangements, and patient-facing services to ensure regulatory compliance.
• Collaborate with Market Access, Compliance, and Patient Services teams on patient access strategies.

Requirements

• Experience advising pharmaceutical or biotechnology companies on healthcare regulatory matters.
• Familiarity with patient access programs, reimbursement support, or copay assistance programs.
• Strong knowledge of Fraud & Abuse laws impacting pharmaceutical programs.
• Experience in pharmaceutical regulatory or compliance environments is preferred.
• Active license and good standing in a U.S. state.

Compensation & Benefits

• Estimated total compensation for full-time attorney roles ranges from $104,500 to $325,000 per year.
• Compensation for non-attorney roles ranges from $71,250 to $309,750 per year.
• Compensation decisions are based on factors including experience, skills, certifications, location, and business needs.
• Additional benefits may include health, dental, and vision insurance; paid holidays and PTO; flexible work arrangements; and professional development opportunities.

Location

This role supports clients in the life sciences sector and may involve collaboration across various teams. Specific location details are not provided.