DEA Compliance Manager: Controlled Substances & Audits

RXinsider LTD.; West Columbia (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

RXinsider LTD. is seeking a DEA Compliance Manager to lead regulatory adherence for controlled substances, manage reporting and audits, and supervise inventory controls. You will serve as a subject-matter expert and power of attorney for registrations while coordinating with regulatory bodies.

The role requires strong project management, technical writing, and regulatory knowledge, with an emphasis on risk reduction and staff training to uphold CFR 21 requirements and DEA standards.

Qualifications

• Bachelor's degree in a scientific discipline with 3–5 years of related experience with controlled substances.
• Thorough knowledge of CFR 21 parts 11, 210, 211, 1300.
• Experience in root cause analysis and technical writing.
• Proven ability to develop and implement solutions for noncompliance.

Responsibilities

• Develop, revise and maintain DEA compliance procedures (documentation, inventory, traceability).
• Manage day-to-day DEA compliance operations across the organization.
• Prepare documentation for DEA reporting (ARCOS, YERS, quotas, destruction, theft/loss).
• Compile state reporting docs for controlled substance transactions.
• Maintain records for controlled substances and ensure secure storage.
• Serve as power of attorney for DEA registrations and 222 forms for Schedule I/II.
• Supervise inventory, reporting and regulatory recordkeeping.
• Support disposal of controlled substance waste per regulations.
• Ensure inspection readiness for DEA/FDA inspections.
• Investigate SOP deviations and implement corrective actions.
• Assess systems and develop improved tracking and reconciliation tools.
• Assist with staff training on DEA compliance requirements.

Skills

Project management

Root cause analysis

Technical writing

Cross-functional collaboration

Regulatory affairs knowledge

Attention to detail

Communication skills

Education

Bachelor's degree in a scientific discipline

Tools

TrackWise

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

RXinsider LTD. is seeking a DEA Compliance Manager to lead regulatory adherence for controlled substances, manage reporting and audits, and supervise inventory controls. You will serve as a subject-matter expert and power of attorney for registrations while coordinating with regulatory bodies.

The role requires strong project management, technical writing, and regulatory knowledge, with an emphasis on risk reduction and staff training to uphold CFR 21 requirements and DEA standards.