Director, 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 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.

Director, Controlled Substance Program

Position Summary

The Director of Regulatory Affairs (Controlled Substances) is responsible for leading all regulatory, operational, and security activities related to controlled substances within a 3PL environment, including compliance with DEA Importer, Distributor, and Exporter registrations. This role ensures comprehensive adherence to DEA regulations (21 CFR Parts 1300–1317), state requirements, customer obligations, and global trade controls.

The Director also leads the company’s Suspicious Order Monitoring System (SOMS) and Controlled Substance Due Diligence Program, ensuring proactive diversion prevention, customer qualification, and compliant distribution practices. This position serves as the main liaison with the DEA, state regulators, and client partners.

Key Responsibilities

Regulatory Compliance & Governance

• Lead the controlled substance compliance program across all Import, Distribution, and Export activities.
• Oversee the design, execution, and continuous improvement of the company’s Suspicious Order Monitoring System (SOMS) to ensure compliant detection, escalation, and reporting of potentially suspicious orders.
• Develop, implement, and maintain a comprehensive Controlled Substance Due Diligence Program, including customer onboarding, ongoing risk assessment, file maintenance, and documentation standards.
• Maintain and renew DEA registrations (Import, Distributor, Export); manage amendments, facility changes, and schedule updates.
• Serve as primary point of contact with DEA and state regulatory bodies, including during inspections, audits, and regulatory inquiries.
• Interpret regulatory updates and lead cross-functional implementation of required changes.
• Oversee all controlled substance SOPs and ensure alignment with DEA requirements, SOMS processes, and client-specific controls.

Operational Oversight

• Direct controlled substance operations across receiving, storage, order fulfillment, transportation, and returns/destruction.
• Ensure compliant management of DEA Form 222, CSOS transactions, ARCOS reporting, inventory adjustments, and import/export notifications.
• Ensure operational alignment with SOMS, including order blocking, review workflows, threshold logic, and documentation of escalation decisions.
• Support customer qualification processes by ensuring operational controls align with Due Diligence Program outcomes.
• Oversee secure storage environments including vaults, cages, monitoring systems, and restricted-access zones.

Security & Diversion Prevention

• Lead diversion-prevention initiatives across the 3PL program, integrating SOMS, Due Diligence, inventory controls, and physical security measures.
• Collaborate with Security, IT, and Operations to maintain DEA-compliant security systems (vaults, alarms, video, access control).
• Direct investigations related to discrepancies, potential diversion events, or SOMS alerts; implement CAPA and preventive measures.
• Ensure employee screening, background checks, and controlled-substance-specific training comply with DEA standards.

Inventory Accountability & Systems

• Oversee controlled substance inventory accuracy through compliant cycle counts, annual inventories, reconciliation, and discrepancy resolution.
• Partner with IT/WMS teams to implement or enhance system controls supporting SOMS logic, order thresholds, traceability, and audit trails.
• Ensure accurate master data, customer authorization records, and system-based safeguards against diversion.

Client & Stakeholder Management

• Serve as the controlled substance subject matter expert for 3PL clients, regulators, and internal teams.
• Lead controlled-substance specific onboarding activities, including SOMS configuration, Due Diligence requirements, and client audits.
• Maintain strong client relationships while ensuring all contractual and regulatory compliance obligations are met.

Leadership & Training

• Lead, mentor, and develop a specialized controlled substance compliance and operations team.
• Oversee training programs covering DEA compliance, SOMS processes, Due Diligence requirements, and diversion prevention.
• Drive a culture centered on regulatory excellence, transparency, and vigilance.

Qualifications

Required

• 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.

Preferred

• Experience managing controlled substances within a high-volume 3PL environment.
• Knowledge of international trade compliance requirements for controlled substance imports and exports.
• Experience with WMS/ERP integrations for SOMS, ARCOS, and CSOS.
• Professional certification in Regulatory, Quality, Supply Chain, or Security.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position

$118,300 - $197,100

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. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) [e-mail] or (Canada) [e-mail]. Resumes or CVs submitted to this email box will not be accepted.

Join us at McKesson!