DEA Compliance Leader: Controlled Substances

Nephron Pharmaceuticals; West Columbia (SC); On-site; USD 95,000 - 140,000; Full time

Job summary

Nephron Pharmaceuticals seeks a DEA Compliance Manager to lead compliance with DEA regulations for controlled substances. You will serve as the subject matter expert and power of attorney for registrations, overseeing policies and procedures to minimize regulatory risk.

The role includes managing documentation, preparing ARCOS/YERS reports, maintaining records, and coordinating with Environmental Affairs for disposal.

Qualifications

• Bachelor's degree in a scientific discipline with 3–5 years of controlled substances experience.
• Thorough knowledge of CFR 21 parts 11, 210, 211, and 1300.
• 3+ years of direct controlled substance program management preferred.
• Experience with DEA and FDA inspections.
• Ability to develop and implement solutions for noncompliance in controlled substances.
• Strong organizational and multi-project management skills.

Responsibilities

• Develop, revise and maintain DEA compliance procedures for controlled substances.
• Manage day-to-day DEA compliance across the organization.
• Assist with DEA reporting (ARCOS, YERS, acquisition, quota, destruction, theft, loss).
• Prepare state-specific reporting for controlled substance transactions.
• Maintain controlled substance records and secure them per regs.
• Serve as power of attorney for DEA registrations and 222 forms.
• Oversee inventory management and reporting of controlled substances.
• Assist with disposal of controlled substance waste with reverse distributors.
• Ensure readiness for DEA and FDA inspections and audits.
• Investigate SOP deviations and propose corrective actions.
• Develop tools to improve tracking and reconciliation of controlled substances.

Skills

DEA inspections

Controlled substances

Root cause analysis

Technical writing

Analytical skills

Communication

Project management

Organizational skills

Collaboration

Education

Bachelor's degree in science

3-5 years pharma experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

TrackWise

Job description

Nephron Pharmaceuticals seeks a DEA Compliance Manager to lead compliance with DEA regulations for controlled substances. You will serve as the subject matter expert and power of attorney for registrations, overseeing policies and procedures to minimize regulatory risk.

The role includes managing documentation, preparing ARCOS/YERS reports, maintaining records, and coordinating with Environmental Affairs for disposal.