Director, Regulatory Affairs

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 ) state requirements customer obligations and global trade controls.

The Director also leads the companys 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 companys 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 crossfunctional 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 systembased safeguards against diversion.

Client & Stakeholder Management

• Serve as the controlled substance subject matter expert for 3PL clients regulators and internal teams.

• Lead controlledsubstance 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

• Bachelors 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 crossfunctional collaboration skills.

Preferred

• Experience managing controlled substances within a highvolume 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.