Director, Regulatory Affairs

• Lead all regulatory, operational, and security activities related to controlled substances within a 3PL environment
• Ensure compliance with DEA Importer, Distributor, and Exporter registrations, DEA regulations, state requirements, customer obligations, and global trade controls
• Lead the Suspicious Order Monitoring System (SOMS) and Controlled Substance Due Diligence Program
• Oversee controlled substance compliance across import, distribution, and export activities
• Design, execute, and improve SOMS detection, escalation, and reporting processes
• Develop and maintain customer onboarding, risk assessment, file maintenance, and documentation standards
• Maintain and renew DEA registrations and manage amendments, facility changes, and schedule updates
• Liaise with the DEA, state regulators, and client partners during inspections, audits, and inquiries
• Interpret regulatory updates and lead cross-functional implementation
• Oversee controlled substance SOPs
• Direct operations across receiving, storage, fulfillment, transportation, and returns/destruction
• Ensure compliant DEA Form 222, CSOS, ARCOS reporting, inventory adjustments, and import/export notifications
• Oversee secure storage environments and DEA-compliant security systems
• Lead diversion-prevention initiatives and investigations
• Implement CAPA and preventive measures for discrepancies, diversion events, and SOMS alerts
• Ensure compliant employee screening, background checks, and controlled-substance training
• Oversee inventory counts, reconciliation, discrepancy resolution, master data, authorization records, and system safeguards
• Partner with IT/WMS teams on SOMS logic, order thresholds, traceability, and audit trails
• Serve as subject matter expert for clients, regulators, and internal teams
• Lead controlled-substance onboarding and client audits
• Maintain client relationships and contractual/regulatory compliance
• Lead, mentor, and develop the controlled substance compliance and operations team
• Oversee training programs and drive a culture of regulatory excellence, transparency, and vigilance

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

Demonstrates expertise in regulatory compliance, particularly with DEA regulations and controlled substances, while leading operational activities in a 3PL environment. Proven ability to manage audits, develop compliance programs, and foster cross-functional collaboration.

• DEA Regulations Expertise
• Controlled Substance Compliance
• SOMS Implementation
• People Leadership
• International Trade Compliance

• Regulatory Compliance
• Controlled Substance Due Diligence
• SOMS Detection and Reporting
• Inventory Management
• Risk Assessment
• Audit Management
• Discrepancy Resolution
• Employee Screening
• Documentation Standards
• Diversion-Control Systems

• Leadership
• Analytical Skills
• Cross-Functional Collaboration
• Mentoring
• Communication

• Regulatory Certification
• Quality Certification
• Supply Chain Certification
• Security Certification

• Controlled Substances
• 3PL Operations
• Pharmaceutical Distribution
• Global Trade Controls
• Compliance Standards

• WMS
• ERP
• DEA Form 222
• CSOS
• ARCOS