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Job Details

Cencora is seeking an experienced healthcare regulatory attorney with significant experience advising and providing strategic leadership in the areas of FDA regulations, fraud and abuse law, CMS regulations and industry guidelines relating to healthcare entities, including pharmaceutical manufacturers, providers and related companies. This role will report to the VP, Data Governance and Regulatory within Cencora’s legal team and focus on enterprise-wide initiatives and risk mitigation strategies. 

This role requires a dynamic leader who will proactively collaborate with team members at all levels of the organization and offer pragmatic, solution-driven advice while managing risk within the highly regulated healthcare industry.   

PRIMARY DUTIES AND RESPONSIBILITIES: 

• Regulatory Compliance: Provide expert legal counsel to senior management and commercial legal teams on a wide range of healthcare regulatory issues, including compliance with federal, state, and local regulations (e.g., Stark Law, Anti-Kickback Statute, False Claims Act, FDA regulations, and CMS guidelines). 

• Risk Mitigation & Management: Identify, assess, and advise on potential legal risks associated with regulatory and operational activities. Develop strategies to mitigate risks and ensure compliance with evolving healthcare laws and regulations. 

• Regulatory Monitoring: Stay abreast of regulatory and legal developments in the healthcare industry and ensure that the organization is prepared for changes in the regulatory landscape. Communicate potential risks and opportunities to senior management and other stakeholders. 

• Government Relations & Agency Interactions: In collaboration with the regulatory and compliance teams, serve as a legal liaison with governmental agencies such as the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General (OIG), the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and other relevant regulatory bodies. Manage responses to audits, investigations, and regulatory inquiries. 

• Transactional Support: Provide regulatory support in mergers, acquisitions, joint ventures, and other strategic business transactions involving healthcare providers, payers, and pharmaceutical companies. Conduct regulatory due diligence and advise on deal structures to minimize legal and regulatory risks. 

• Healthcare Fraud and Abuse: Advise on compliance with federal and state healthcare fraud and abuse laws, including structuring business arrangements (e.g., physician compensation arrangements, referral agreements, and contracting structures) to comply with the Anti-Kickback Statute, Stark Law, and similar state laws. 

• FDA and Pharmaceutical Guidelines: Provide guidance on drug development, approval, marketing, and post-market surveillance. Knowledge of PIE, transparency, price reporting, private label and country of origin a requirements a plus. 

• Training and Education: Develop and lead internal training programs on regulatory matters, helping to ensure that key stakeholders, including compliance teams, business leaders, and staff, understand and comply with healthcare regulatory requirements. 

• Contractual Review and Compliance: Review and provide legal guidance on healthcare-related agreements, including payer/provider contracts, supplier agreements, and vendor relationships, to ensure compliance with healthcare re