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 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 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 Core Competencies 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. Highest-signal resume keywords DEA Regulations Expertise Controlled Substance Compliance SOMS Implementation People Leadership International Trade Compliance Hard Skills 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 Soft Skills Leadership Analytical Skills Cross-Functional Collaboration Mentoring Communication Certifications & Qualifications Regulatory Certification Quality Certification Supply Chain Certification Security Certification Industry Keywords Controlled Substances 3PL Operations Pharmaceutical Distribution Global Trade Controls Compliance Standards Tools & Technologies WMS ERP DEA Form 222 CSOS ARCOS #J-18808-Ljbffr Jobtailor