Director, Regulatory Affairs

McKesson•Shepherdsville, KY

1d•$118,300 - $197,100

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.
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.