DEA Compliance & Controlled Substances Lead

Nephron Pharmaceuticals Corporation; Columbia (SC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Nephron Pharmaceuticals Corporation seeks a DEA Compliance Manager to ensure adherence to DEA regulations and manage controlled substances programs across the organization.

The role acts as the subject matter expert for controlled substances, handles registrations and reporting, and collaborates with regulatory bodies to maintain inspection readiness and compliance with CFR 21 parts 11, 210, 211, 1300.

Qualifications

• Bachelor's degree in a scientific discipline; 3–5 years with controlled substances, or 3–5 years in pharma using controlled substances preferred.
• Thorough knowledge of CFR 21 parts 11, 210, 211, and 1300.

Responsibilities

• Develop, revise and maintain DEA compliance procedures (documentation, inventory, traceability).
• Manage day-to-day DEA compliance across the organization.
• Assist with DEA reporting (ARCOS, YERS, quota, destruction, theft/loss).
• Assist with state reporting requirements for controlled substances.
• Maintain records for controlled substances and secure records per regs.
• Serve as power of attorney for DEA registrations and 222 forms.

Skills

DEA compliance

Controlled substances

Regulatory inspections

Root cause analysis

Technical writing

Project coordination

MS Word

MS Excel

PowerPoint

TrackWise

Cross-functional collab

Education

Bachelor's in Science

Tools

TrackWise

Job description

Nephron Pharmaceuticals Corporation seeks a DEA Compliance Manager to ensure adherence to DEA regulations and manage controlled substances programs across the organization.

The role acts as the subject matter expert for controlled substances, handles registrations and reporting, and collaborates with regulatory bodies to maintain inspection readiness and compliance with CFR 21 parts 11, 210, 211, 1300.