DEA Compliance Consultant

Pharmatech is proud to be an equal opportunity employer. Together we are committed to fostering an environment that is professional, inclusive and diverse. Explore the exciting opportunities currently available in the US and around the world.

Pharmatech Associates is seeking an experienced DEA Compliance Consultant / Subject Matter Expert (SME) for a consulting engagement. The primary objective of this assignment is to evaluate a client's proposed DEA-regulated operations and determine the feasibility of moving forward with manufacturing. The consultant will conduct an operational and compliance assessment, identify regulatory and business risks, evaluate the client's current state, and recommend areas where Pharmatech Associates can provide consulting and implementation support.

• Review the client's proposed business model, facility plans, operational workflows, and controlled substance activities.
• Evaluate the client's readiness to support DEA-regulated manufacturing, distribution, storage, laboratory, or supply chain operations.
• Assess existing processes, documentation, and compliance programs against DEA regulations and industry best practices.
• Identify compliance gaps, operational risks, and areas requiring further development.
• Develop a comprehensive assessment report outlining findings, risks, recommendations, and opportunities for Pharmatech Associates to support the client.
• Present findings and recommendations to Pharmatech Associates and the client to assist with project go/no-go decisions

• Evaluate manufacturing, warehouse, laboratory, and distribution operations to ensure controlled substance processes meet DEA requirements and business objectives.
• Advise on compliant workflows for receiving, weighing, dispensing, manufacturing, packaging, storage, shipping, returns, and destruction of controlled substances.
• Collaborate with Operations, Manufacturing, Supply Chain, Quality, Engineering, Security, and Regulatory Affairs to strengthen operational compliance.
• Recommend practical process improvements that enhance both operational efficiency and regulatory compliance.

• Assess inventory control systems for raw materials, APIs, work-in-process (WIP), finished goods, samples, and returned controlled substances.
• Evaluate reconciliation processes and material accountability throughout manufacturing and distribution.
• Support inventory programs, discrepancy investigations, and chain-of-custody controls.

• Evaluate controlled substance storage and handling areas, including vaults, cages, manufacturing suites, laboratories, warehouses, and shipping/receiving operations.
• Assess physical security, access controls, surveillance, alarm systems, and diversion prevention measures.
• Recommend improvements aligned with DEA expectations and operational requirements.

• Develop or enhance SOPs, work instructions, and operational controls supporting DEA-regulated activities.
• Assist with diversion prevention programs, suspicious order monitoring (SOM), customer due diligence, and internal compliance monitoring.
• Support development of sustainable compliance programs tailored to the client's business model.

• Conduct operational assessments, mock DEA inspections, and internal audits.
• Identify compliance gaps and assist in developing corrective and preventive action (CAPA) plans.
• Support investigations involving inventory discrepancies, security events, or operational compliance issues.

• Provide expertise on the Controlled Substances Act (CSA), DEA regulations (21 CFR Parts 1300–1321), and applicable state regulations.
• Assist with ARCOS reporting, DEA Forms 222/CSOS, DEA Form 106, quota management, and other regulatory requirements, as applicable.
• Interpret regulatory expectations and translate them into practical operational solutions.

• Develop and deliver training for manufacturing, warehouse,…