DEA Compliance Specialist

DEA Compliance Specialist

The DEA Compliance Specialist manages federal regulatory compliance for handling, storing, manufacturing, and distributing controlled substances. The Specialist will oversee DEA reporting, inventory control, form coordination and submittal, year-end reconciliation activities, as well as research, implementation, and maintenance of security protocols. The DEA Compliance Specialist will also be a key liaison for Drug Enforcement Administration audits in partnership with the Site Quality and Supply Chain teams.

Responsibilities

• Understand and interpret DEA regulations and identifies areas of opportunity to improve policies, procedures, and practices for compliance with applicable rules and regulations; implement approved improvement plans.
• Manage monthly, quarterly and annual reporting, including accurate DEA ARCOS transactions and support of quota management for scheduled drugs.
• Coordinate, complete and submit required DEA Forms such as DEA222's for compliance with DEA requirements.
• Assess site security measures in accordance with DEA guidelines, make recommendations for improvement where needed; implement approved plans.
• Serves as a key, at times the primary, point of contact for DEA and state-controlled substance regulatory inspections.
• Ensure proper security controls are in place for shipping and receiving controlled drugs.
• Review cGMP documentation related to controlled substances.
• Oversee secure destruction processes, coordinates with local DEA offices, and processes DEA Form 41 documentation.
• Oversee physical inventory accountability and reconciliation for controlled substances, including end-of-year reconciliation practices.
• Manage controlled substance handling to ensure DEA regulation compliance.
• Monitor all licensing requirements regarding the handling of controlled material.
• Train manufacturing and warehouse personnel on compliant handling, logging, and chain-of-custody protocols.
• Manage, execute, and support audit program to confirm and proactively ensure compliance.
• Lead Anti-Diversion due diligence program to minimize diversion potential through audits, training, security programs and investigations.
• Remain current with industry practices/trends and regulatory agency expectations governing controlled substance handling and reporting, and supply chain security industry practices.
• Other duties as assigned.

Experience, Education, and Skills Required

• Bachelor's degree and 3+ years of regulatory compliance or operations experience within an FDA- or DEA-regulated pharmaceutical environment (CDMO/CMO experience preferred), or an equivalent combination of education and work experience with acquired transferrable skills
• Knowledge and interpretation of DEA regulations and industry guidance's, policies, and procedures pertaining to the DEA Controlled Substance and/or supply chain security.
• Previous experience working directly with regulatory agency(ies), or in law enforcement
• Meticulous record-keeping, and ability to research, interpret, and implement regulatory requirements
• High attention to detail, strong cross-functional communication, and sound audit-management capabilities.
• Ability to work effectively in high pressure situations

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

Principals Only No Agencies Or Third Parties