Director, Controlled Substances

Director Of Controlled Substance Management

The Director of Controlled Substance Management will oversee the development, implementation, and monitoring of programs and policies to ensure the organization's compliance with federal, state, and local regulations governing controlled substances. This role requires a strong understanding of regulatory frameworks, including DEA (Drug Enforcement Administration) regulations and the Bureau of Narcotic Enforcement (BNE), as well as the ability to lead cross-functional teams to maintain compliance and mitigate risks associated with controlled substance handling.

The Director will collaborate with internal stakeholders, including R&D, veterinarian staff, research chemistry, compliance, and legal teams, to ensure the organization adheres to all applicable laws and regulations. This position is critical to maintaining the integrity of the organization's controlled substance program and ensuring the safe and lawful management of controlled substances throughout their lifecycle.

A Typical Day In This Role Might Look Like :

• Develop, implement, and maintain comprehensive policies and procedures for the management of controlled substances in compliance with DEA, BNE, FDA, and other regulatory requirements.
• Serves as a Subject Matter Expert in the interpretation of 21 CFR 1300.
• Monitor and interpret changes in controlled substance regulations and ensure organizational policies are updated accordingly.
• Serve as the primary point of contact for regulatory agencies, including managing DEA inspections and audits.
• Provide backup support to Controlled Substance Compliance Specialist to complete daily tasks as required.
• Oversee the tracking, documentation, and reconciliation of controlled substance inventories across all locations to ensure accurate record-keeping and compliance. Implement systems and processes for monitoring controlled substance usage, storage, and disposal to prevent diversion and ensure accountability.
• Work closely with R&D, compliance and legal teams to ensure controlled substance compliance.
• Provide guidance and training to employees on controlled substance policies and procedures.
• Conduct regular audits and risk assessments to identify potential compliance gaps or vulnerabilities in controlled substance management.
• Lead investigations into controlled substance discrepancies, losses, or diversions, and implement corrective actions as needed.
• Design and deliver training programs for employees on controlled substance regulations and internal policies.
• Foster a culture of compliance and accountability through ongoing education and communication.
• Ensure meticulous records of controlled substance activities, including inventory logs, audit reports, and regulatory filings are managed.
• Prepare and submit required reports to regulatory agencies in a timely manner.

This Role Might Be For You If :