Director, Regulatory Affairs

Jobtailor; Kentucky; On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor in the United States seeks a senior regulatory/compliance leader to oversee all controlled substances activities within a high-volume 3PL setting. The role ensures DEA registrations, global trade controls, and DUR/CSOS/ARCOS reporting across import, distribution, and export processes.

The candidate will drive the SOMS program, due diligence, audits, and cross-functional collaboration, while mentoring the compliance and operations teams to maintain regulatory excellence and client trust.

Qualifications

• Bachelor’s degree or equivalent 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.

Responsibilities

• Lead regulatory, operational, and security activities related to controlled substances within a 3PL environment.
• Ensure compliance with DEA registrations and regulations across import, distribution, and export.
• Oversee the SOMS and Controlled Substance Due Diligence Program.
• Direct operations across receiving, storage, fulfillment, transportation, and returns/destruction.
• Design and improve SOMS detection, escalation, and reporting processes.

Skills

Regulatory compliance

SOMS implementation

Leadership

Cross-functional collaboration

Audit management

Documentation standards

Employee screening

Risk assessment

Education

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

Tools

WMS

ERP

DEA Form 222

CSOS

ARCOS

Job description

• 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