DEA Compliance & Security Specialist

Adare Pharma Solutions; Vandalia (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Adare Pharma Solutions in Vandalia, OH is seeking a DEA Compliance Specialist to oversee federal regulatory compliance for handling, storing, manufacturing, and distributing controlled substances. The Specialist will manage DEA reporting, inventory control, form coordination and submittal, year-end reconciliation activities, as well as research, implementation, and maintenance of security protocols.

The DEA Compliance Specialist will also be a key liaison for Drug Enforcement Administration

Qualifications

• Bachelor’s degree and 3+ years of regulatory compliance or operations experience in FDA- or DEA-regulated pharmaceutical environment.
• Knowledge of DEA regulations and industry guidance pertaining to the DEA Controlled Substance and/or supply chain security.
• Experience working with regulatory agencies or in law enforcement.
• Meticulous record-keeping and ability to research, interpret, and implement regulatory requirements.
• Strong audit-management capabilities and cross-functional collaboration.

Responsibilities

• Understand and interpret DEA regulations; implement approved improvement plans.
• Manage monthly, quarterly and annual reporting, including DEA ARCOS transactions and quota management.
• Coordinate and submit DEA Forms (e.g., DEA 222s) for compliance.
• Assess site security measures per DEA guidelines and implement improvement plans.
• Serve as primary contact for DEA/state inspections and regulatory audits.
• Ensure security controls for shipping/receiving controlled substances.
• Review cGMP documentation related to controlled substances.
• Oversee secure destruction processes and DEA Form 41 documentation.
• Oversee inventory accountability and end-of-year reconciliation for controlled substances.
• Monitor licensing requirements regarding controlled material.
• Train personnel on compliant handling, logging, and chain-of-custody.
• Lead audit programs to confirm compliance and minimize risks.
• Drive Anti-Diversion due diligence through audits and security programs.
• Stay current with regulatory expectations governing controlled substances and supply chain security.
• Other duties as assigned.

Skills

Regulatory compliance

DEA regulations

Audit management

Cross-functional communication

Attention to detail

High-pressure work

Education

Bachelor’s degree

Job description

Adare Pharma Solutions in Vandalia, OH is seeking a DEA Compliance Specialist to oversee federal regulatory compliance for handling, storing, manufacturing, and distributing controlled substances. The Specialist will manage DEA reporting, inventory control, form coordination and submittal, year-end reconciliation activities, as well as research, implementation, and maintenance of security protocols.

The DEA Compliance Specialist will also be a key liaison for Drug Enforcement Administration