Regulatory Affairs Manager, Controlled Substances Monitoring Program

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.

About the Role

McKesson is seeking a Regulatory Affairs Manager to join the Strategic Accounts team within our Regulatory Affairs Controlled Substances Monitoring Program (CSMP). This individual contributor role supports customer due diligence for strategic account customers within McKesson’s U.S. Pharmaceutical Distribution business.

Reporting to a Director of Regulatory Affairs, you will conduct and document customer due diligence assessments, analyze pharmacy ordering and dispensing data, and partner with Sales, Legal, Compliance, Operations, and other stakeholders on controlled substance compliance matters.

This is an individual contributor role with no direct reports. The successful candidate will work independently while building effective partnerships across internal teams and with corporate compliance teams at national pharmacy organizations.

What You’ll Do

Conduct comprehensive customer due diligence assessments for strategic account pharmacies in accordance with Controlled Substances Monitoring Program (CSMP) policies and procedures.

Prepare clear, concise written reports documenting due diligence assessments, analysis, findings, and supporting information.

Analyze pharmacy ordering, dispensing, and other relevant customer data to support regulatory compliance and due diligence activities.

Apply data analysis and sound judgment to evaluate information from multiple sources and support informed regulatory decisions.

Collaborate with Sales, Legal, Compliance, Operations, and other internal stakeholders on matters involving strategic account customers.

Serve as a Regulatory Affairs liaison with corporate compliance teams at national pharmacy organizations, building productive partnerships while maintaining regulatory and compliance standards.

Manage multiple assessments and competing priorities while meeting established deadlines.

Maintain knowledge of emerging trends related to pharmacy operations, controlled substance compliance, diversion control, pharmaceutical distribution, and healthcare data analytics.

Basic Requirements

Degree or equivalent and typically requires 4+ years of relevant experience.

Demonstrated experience analyzing data and information from multiple sources to support business, compliance, regulatory, or risk-based decisions.

Professional experience preparing written reports, assessments, or similar documentation requiring analysis and attention to detail.

Preferred Skills/Experience

Experience in regulatory affairs, regulatory compliance, controlled substance compliance, healthcare compliance, pharmaceutical distribution, pharmacy operations, or a related field.

Knowledge of controlled substance compliance, diversion control programs, or applicable healthcare regulatory requirements.

Experience conducting customer due diligence, compliance reviews, risk assessments, investigations, audits, or similar analytical reviews.

Understanding of retail, chain, or health system pharmacy operations.