Regulatory Affairs Manager

Regulatory Affairs Manager

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 Regulatory Affairs Manager. This is a remote, work-from-home position, preferably based in the Dallas–Fort Worth Metroplex, Texas. Other locations considered are: Arkansas, Illinois, Kansas, Louisiana, Mississippi, Missouri, Oklahoma.

This role's primary responsibility is to support the regional Director of Regulatory Affairs (DRA) by conducting customer due diligence assessments focused on McKesson's U.S. Pharmaceutical Distribution accounts and in accordance with McKesson's Controlled Substances Monitoring Program (CSMP). This will require interaction and partnership with internal teams, report writing and data analysis, and interaction with DRAs to evaluate findings from the aforementioned activities.

Key Responsibilities

• Conduct customer site visits as necessary to support CSMP processes.
• Perform customer due diligence reviews that include assessments of prospective customers and ongoing assessments of current customers.
• Review and analyze data to support due diligence efforts and identify/validate controlled substance trends and sourcing profiles.
• Prepare written reports to document reviews and statistical analysis.
• Engage with account managers and customers, as well as internal team personnel as needed to support the CSMP process.
• Drive CSMP process awareness and communication with Sales and individual Account Managers.
• Seek opportunities to improve CSMP operational excellence through people, processes, or technology.

Minimum Requirement

Degree or equivalent and typically requires 4+ years of relevant experience. Education Four-year degree in a related field or equivalent experience

Critical Skills

• 4+ years of experience managing regulatory compliance in the pharmaceutical supply chain, with a focus on controlled substance compliance (Pharmacy, DEA experience, or law enforcement background preferred).
• Strong ability to learn quickly and adapt in fast-paced environments.
• Proven collaboration skills across cross-functional teams.
• In-depth knowledge of retail pharmacy operations, controlled substance compliance, and diversion control programs.
• Expertise in making data-driven, strategic decisions based on thorough analysis.
• Excellent relationship-building and people engagement skills.
• Working knowledge of Federal and State regulations related to controlled substance compliance.
• Proficiency in MS Office (Word, PowerPoint, Excel).

Additional Skills

• Excellent communication, collaboration, and influencing skills at all levels of the organization.
• Proficient interviewing and technical writing skills, attention to detail.
• Strong Analytical Skills.
• Experience with Tableau, SAP, and Salesforce.
• Results Orientation and Energy.
• Building Relationships.
• Mature Confidence and Integrity.
• Assertiveness and Influence.

Physical Requirements

• Traditional office requirements. A large percentage of time performing computer-based work is required.
• 10% travel for client visits.

This role is a hybrid position if you live near DFW. The selected candidate is 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 based on team needs and business priorities.

Work Authorization: Must be authorized to work in the U.S. Sponsorship is not available for this position

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.