Director, Controlled Substances Compliance & SOMS

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

Job summary

McKesson seeks a Director of Regulatory Affairs (Controlled Substances) to lead regulatory, operational, and security activities in a 3PL setting. You will manage DEA registrations, SOMS, and Due Diligence to prevent diversion and ensure client compliance.

You will liaison with DEA and regulators, build cross-functional programs, and mentor a specialized team. This role demands deep regulatory expertise and strong leadership in a high-volume environment.

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field.
• 12+ years in regulated substances within pharma/3PL.
• Expertise with DEA regulations, SOMS, and Due Diligence programs.
• Experience interacting with DEA inspectors and leading audits.
• Strong leadership and cross-functional collaboration.

Responsibilities

• Lead controlled substance compliance across imports, distribution, and exports.
• Oversee SOMS design, optimization, and reporting.
• Develop and maintain a Comprehensive Due Diligence Program and onboarding.
• Maintain and renew DEA registrations; manage amendments.
• Serve as primary liaison with DEA and regulators.
• Interpret regulatory updates and drive cross-functional changes.
• Oversee SOPs aligned with DEA and SOMS.

Skills

Leadership

Cross-functional collaboration

Regulatory compliance

DEA regulations

SOMS

Education

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

Professional certification in Regulatory, Quality, Supply Chain, or Security

Tools

WMS integrations

ERP integrations

ARCOS

CSOS

Job description

McKesson seeks a Director of Regulatory Affairs (Controlled Substances) to lead regulatory, operational, and security activities in a 3PL setting. You will manage DEA registrations, SOMS, and Due Diligence to prevent diversion and ensure client compliance.

You will liaison with DEA and regulators, build cross-functional programs, and mentor a specialized team. This role demands deep regulatory expertise and strong leadership in a high-volume environment.