Director, Regulatory Affairs - Controlled Substances & SOMS

McKesson Corporation; Shepherdsville (KY); On-site; USD 118,000 - 197,000; Full time

Benefits offered by this job

Total Rewards package

Job summary

McKesson is seeking a Director of Regulatory Affairs (Controlled Substances) to lead regulatory, operational, and security activities within a 3PL environment, ensuring DEA registrations and ongoing compliance.

The role oversees the SOMS and Due Diligence programs, serves as the primary liaison with the DEA and state regulators, and drives improvements in security, inventory controls, and audits across receiving, storage, and distribution.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, Supply Chain, or related field.
• 12+ years of experience in controlled substances in pharma, distribution, or 3PL operations, with 5+ years of people leadership experience.
• Expertise with DEA regulations, diversion-control systems, SOMS, and Due Diligence programs.
• Experience interacting directly with DEA inspectors and leading audits.
• Strong leadership, analytical, and cross-functional collaboration skills.

Responsibilities

• Lead the controlled substance compliance program across Import, Distribution, and Export.
• Oversee design, execution, and continuous improvement of SOMS for compliant detection and reporting.
• Develop and maintain a Controlled Substance Due Diligence Program with onboarding and risk assessment.
• Maintain and renew DEA registrations; manage amendments and schedule updates.
• Serve as primary liaison with DEA and state regulators during inspections and inquiries.
• Oversee SOPs aligned with DEA requirements and SOMS processes.
• Direct controlled substance operations across receiving, storage, and returns/destruction.
• Ensure compliant management of DEA Form 222, CSOS, ARCOS, inventory adjustments.
• Ensure secure storage environments and restricted-access controls.
• Lead onboarding activities, audits, and client relationships for 3PL programs.
• Drive training programs and a culture of regulatory excellence.

Skills

Leadership

Regulatory affairs

Cross-functional collaboration

Audit experience

DEA compliance

Education

Bachelor's degree in Life Sciences, Regulatory Affairs, Supply Chain, or related field

Tools

WMS/ERP integrations

SOMS software

ARCOS reporting system

CSOS transaction systems

Job description

McKesson is seeking a Director of Regulatory Affairs (Controlled Substances) to lead regulatory, operational, and security activities within a 3PL environment, ensuring DEA registrations and ongoing compliance.

The role oversees the SOMS and Due Diligence programs, serves as the primary liaison with the DEA and state regulators, and drives improvements in security, inventory controls, and audits across receiving, storage, and distribution.