Regulatory Affairs Manager, Regulatory Affairs, Controlled Substances Monitoring Program (CSMP) – Strategic Accounts
About the position 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. We are seeking a dynamic and analytical Regulatory Affairs Manager to join the Strategic Accounts team within our Regulatory Affairs Controlled Substances Monitoring Program (CSMP) department. This remote role reports directly to a Director of Regulatory Affairs and plays a critical role in conducting due diligence assessments focused on McKesson’s U.S. Pharmaceutical Distribution (USPD) strategic account customers in accordance with McKesson’s CSMP. This is an individual contributor role with no direct reports. The successful candidate will operate independently while collaborating cross-functionally with internal and external stakeholders. The ideal candidate will bring a strong background in data analytics, strategic communication, and regulatory or controlled substance compliance or enforcement matters, with a passion for driving compliance excellence. This individual must be flexible, able to manage multiple competing priorities, and maintain strong organizational skills. The ability to self-direct workflow, meet deadlines, and align deliverables with the operational tempo of the department is essential. Responsibilities • Conduct comprehensive customer due diligence assessments for strategic account pharmacies in alignment with CSMP policies and procedures and develop clear and concise reports documenting assessments. • Analyze data to support due diligence processes, including through assessing customer ordering and dispensing data. • Collaborate with internal stakeholders (Sales, Legal, Compliance, Operations) on matters relating to strategic account customers. • Serve as a liaison with corporate compliance teams at national pharmacy chains, fostering strong partnerships while maintaining regulatory integrity. • Stay informed on emerging trends in pharmacy operations, controlled substance compliance, and healthcare data analytics. Requirements • Degree or equivalent and typically requires 4+ years of relevant experience. • Ability to make strategic, logic-based, and educated decisions leveraging data, analysis, and information from a variety of sources. • Strong writing and documentation skills with a keen attention to detail and ability to clearly communicate complex information. • Sound judgment and confidence in navigating complex discussions while maintaining a professional and collaborative approach. • Ability to work independently in a remote environment while being receptive to feedback and adaptable to change. Nice-to-haves • Knowledge of controlled substance compliance, diversion control programs, or healthcare regulatory frameworks. • Experience in pharmacy operations, clinical practice, or healthcare compliance is highly desirable. • Strong interpersonal skills with the ability to build trust and influence across diverse teams and external partners. • Demonstrated experience in data analysis, including proficiency in tools such as Excel, Tableau, Power BI, or similar platforms. Apply tot his job