Regulatory Affairs, DEA Compliance Specialist
St. Louis, MO
Title: Regulatory Affairs and DEA Compliance Specialist
Primary Responsibilities and Essential Functions of the Position:
- Manage and enforce compliance procedures to operate a cGMP manufacturing facility to meet DEA regulations to prevent material diversion.
- Conduct and/or support internal audits, client audits, and regulatory audits including, but not limited to: audit scheduling, preparation, execution, response/resolution, and follow-up.
- Manage controlled substance handling to ensure DEA regulation compliance.
- Audit lab log books to ensure compliance.
- Maintain controlled substance inventory of both incoming and outgoing bulk and in-process materials as well as their final disposition.
- Manage all DEA requirements including applications, vendor verification's, and procurement of controlled substances and update SOPs as necessary.
- Assist with the completion of all DEA reports including ARCOS reports and audits, as required.
- Provide project team representation and direction in managing information from/to other departments (including Product Development, Manufacturing, and Quality) regarding regulatory submissions to government agencies. This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.
- Prepare or direct the preparation of additional information or responses for drug applications as requested by regulatory agencies.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Provide compliance training to facility staff.
- Perform other duties as required and assigned.
Skills and Abilities Required:
- Knowledge of Federal DEA and State of MO regulations involving controlled substances and Listed Chemicals.
- Knowledge of pharmaceutical manufacturing practices, validation methods, inspection, and testing methodologies.
- Current knowledge base of existing and emerging regulations, standards, or guidance documents relating to drug applications.
- Strong organizational skills with high attention to detail.
- Proficient with Microsoft Office (Word, Excel, Access, Outlook).
- Strong writing and editing skills.
Minimum Education and Experience Required:
- Bachelor’s degree in related discipline.
- Minimum of three (3) years of experience working with DEA and Regulatory submissions.
- Proficient in DEA reporting software (ARCOS, YERS, and Quota submissions, etc.).