Regulatory Affairs Manager, Controlled Substances Monitoring Program

MCK McKesson Corporation; Irving (TX); Hybrid; USD 85,000 - 142,000; Full time

Job summary

McKesson in Irving, Texas is seeking a Regulatory Affairs Manager to join the Strategic Accounts team within the CSMP program. This role will conduct customer due diligence, analyze pharmacy data, and partner with Sales, Legal, Compliance, and Operations on controlled substance compliance matters.

The successful candidate will prepare clear written reports, manage multiple assessments, and stay updated on regulatory trends in pharmacy operations and healthcare data analytics.

Qualifications

• 4+ years of relevant regulatory or risk experience.
• Experience analyzing data from multiple sources to support decisions.
• Experience preparing written reports or assessments requiring analysis and attention to detail.
• Knowledge of regulatory requirements in healthcare or controlled substances.

Responsibilities

• Conduct customer due diligence assessments for strategic account pharmacies.
• Prepare written reports documenting due diligence assessments and findings.
• Analyze pharmacy data to support regulatory compliance and due diligence.
• Collaborate with Sales, Legal, Compliance, and Operations on regulatory matters.
• Serve as liaison with national pharmacy organizations on compliance matters.
• Manage multiple assessments and deadlines while maintaining quality.
• Maintain knowledge of trends in pharmacy operations and healthcare data analytics.

Skills

Data analysis

Written reports

Communication skills

Excel

Tableau

Power BI

Stakeholder collaboration

Education

Bachelor's degree

Tools

Tableau

Power BI

Excel

Job description

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.
• 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 with the ability to independently manage multiple priorities and deadlines.
• Demonstrated ability to collaborate and influence across cross-functional teams and external partners.

Description of Travel or In-Office and Physical Requirements

Travel: Up to 5% annually. Location: Remote role; Irving, Texas (Las Colinas) is highly preferred. Ability to work independently in a remote environment and collaborate effectively with geographically distributed teams. This position offers the possibility of a hybrid work arrangement based on recent updates to our in-office/work-from-home model. If located in DFW area, the selected candidate may be expected to work on-site at our Las Colinas office a minimum of two (2) days per week, with the remaining days worked remotely. Specific in-office days may be designated according to team needs and business priorities.

McKesson complies with all applicable U.S. immigration laws and regulations. The Company does not provide employer support or sponsorship for any immigration related employment benefit for this role. Applicants must be currently authorized to work in the United States on a fulltime basis without the need for employer support or sponsorship now or in the future.

Our Base Pay Range for this position $85,100 - $141,800.

McKesson is an Equal Opportunity Employer. McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities.

If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) [e-mail] or (Canada) [e-mail].