Director of Controlled Substances Regulatory Affairs

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

Benefits offered by this job

Total Rewards package

Bonus opportunities

Job summary

McKesson seeks a Director of Regulatory Affairs (Controlled Substances) to lead regulatory, operational, and security activities in a 3PL environment, ensuring DEA registrations, SOMS, and due diligence programs are compliant.

You will serve as the primary liaison with the DEA and state regulators, oversee SOPs, inventory controls, and client onboarding, and build a high-performing team dedicated to diversion prevention and regulatory excellence.

Qualifications

• Bachelor's degree required in Life Sciences, Regulatory Affairs, or related field.
• 12+ years controlled substances in pharma/3PL, with 5+ years people leadership.
• Experience with DEA regs, SOMS, and Due Diligence programs.
• Experience interacting with DEA inspectors and leading audits.

Responsibilities

• Lead the controlled substance compliance program across Import, Distribution, and Export.
• Oversee design and operation of the SOMS for detection, escalation, and reporting.
• Develop, implement, and maintain the Controlled Substance Due Diligence Program.
• Maintain and renew DEA registrations; manage changes and schedule updates.
• Serve as primary contact with DEA/state regulators during inspections/audits.
• Oversee SOPs, inventory controls, and client-specific controls.
• Lead investigations and CAPA for diversion-related issues.

Skills

Regulatory affairs

DEA regulations

Leadership

Cross-functional

Audits

Education

Bachelor's degree in Life Sciences/Regulatory Affairs/Supply Chain

Tools

SOMS

ARCOS

CSOS

WMS/ERP

Job description

McKesson seeks a Director of Regulatory Affairs (Controlled Substances) to lead regulatory, operational, and security activities in a 3PL environment, ensuring DEA registrations, SOMS, and due diligence programs are compliant.

You will serve as the primary liaison with the DEA and state regulators, oversee SOPs, inventory controls, and client onboarding, and build a high-performing team dedicated to diversion prevention and regulatory excellence.