Regulatory Affairs Manager

About This Role

This role primarily supports the Director of Regulatory Affairs by conducting customer due diligence assessments for pharmaceutical solutions and services accounts. It involves ensuring compliance with McKesson’s Controlled Substances Monitoring Program (CSMP) and will require interaction with internal teams, report writing, and data analysis.

Responsibilities

• Conduct customer site visits to support CSMP processes
• Perform customer due diligence reviews for prospective and 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, customers, and internal team personnel 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

Requirements

• 4+ years of relevant experience
• Multiple years’ experience with responsibility for regulatory compliance in the supply chain for the pharmaceutical industry
• In-depth understanding of retail pharmacy operations, controlled substance compliance, and diversion control programs
• Working knowledge of Federal and State governmental regulations pertaining to controlled substance compliance
• Advanced proficiency with MS Office (Word, PowerPoint, Excel)

Qualifications

• 4+ years of relevant experience, with multiple years in regulatory compliance in the pharmaceutical supply chain

Nice to Have

• Controlled substance compliance experience
• Pharmacy experience
• DEA experience
• Law enforcement background
• Experience with Tableau
• Experience with SAP
• Experience with Salesforce

Skills

* Required skills

Benefits