Regulatory Affairs Manager, Controlled Substances Monitoring Program

McKesson•Irving, TX

7d•Remote

About The Position

McKesson is seeking a Regulatory Affairs Manager to join the Strategic Accounts team within its 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. The position reports to a Director of Regulatory Affairs and has no direct reports. The successful candidate will independently conduct and document customer due diligence assessments, analyze pharmacy ordering and dispensing data, and collaborate with Sales, Legal, Compliance, Operations, and other stakeholders on controlled substance compliance matters. The role also involves building effective partnerships with corporate compliance teams at national pharmacy organizations while maintaining regulatory and compliance standards. The position is remote, with Irving, Texas (Las Colinas) highly preferred. A hybrid arrangement may apply based on McKesson’s in-office/work-from-home model; candidates located in the DFW area may be expected to work at the Las Colinas office at least two days per week. Travel is up to 5% annually. Applicants must be authorized to work in the United States without current or future employer immigration support or sponsorship.

Requirements

Degree or equivalent; typically requires 4 or more 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 analytical documentation requiring attention to detail.
Ability to work independently in a remote environment and collaborate effectively with geographically distributed teams.
Applicants must be currently authorized to work in the United States on a full-time basis without employer immigration support or sponsorship now or in the future.

Nice To Haves

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.
Experience analyzing pharmacy ordering, dispensing, prescription, or other healthcare-related data.
Proficiency with analytical and reporting tools such as Microsoft Excel, Tableau, Power BI, or similar platforms.
Strong written and verbal communication skills, including the ability to communicate complex regulatory or analytical information clearly.
Ability to exercise sound judgment and navigate complex discussions with internal and external stakeholders.
Strong organizational skills and ability to independently manage multiple priorities and deadlines.
Demonstrated ability to collaborate and influence across cross-functional teams and external partners.

Responsibilities

Conduct comprehensive customer due diligence assessments for strategic account pharmacies in accordance with CSMP policies and procedures.
Prepare clear, concise written reports documenting assessments, analysis, findings, and supporting information.
Analyze pharmacy ordering, dispensing, and other relevant customer data for regulatory compliance and due diligence activities.
Evaluate information from multiple sources using data analysis and sound judgment to support informed regulatory decisions.
Collaborate with Sales, Legal, Compliance, Operations, and other internal stakeholders on strategic account customer matters.
Serve as a Regulatory Affairs liaison with corporate compliance teams at national pharmacy organizations.
Manage multiple assessments and competing priorities while meeting established deadlines.
Maintain knowledge of emerging trends in pharmacy operations, controlled substance compliance, diversion control, pharmaceutical distribution, and healthcare data analytics.