Regulatory Affairs and DEA Compliance Specialist


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Regulatory Affairs and DEA Compliance Specialist

Fenton, Missouri Direct Job ID: 2010114488

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Description
Regulatory Affairs and DEA Compliance Specialist
Direct Hire
Location: Saint Louis, MO (Fenton)
Shift: 8 to 5 (M-F)



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 verifications, 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.).
More Details

PDS Tech, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Founded in 1977, PDS Tech, Inc. is one of the nation's premier specialty staffing firms with 31 offices nationwide. We offer a full range of benefits including:

  • Health insurance
  • Paid holidays
  • Weekly payroll
  • Immediate 401(k) eligibility
  • Completion Bonuses
  • Training
  • Please note availability of benefits may vary by position

PDS specializes in Engineering and IT arenas including Aerospace, Defense, Electronics, Telecommunications, Automotive, and Energy just to name a few. Our reputation, track record, and years of continuous growth reflect the commitment to quality that our employees and clients experience first-hand. To find out more about PDS, please visit www.pdstech.com

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We pay thousands each month in referral bonuses!
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PDS Tech, Inc. is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities.
If you need special assistance or an accommodation while seeking employment, please click here or call 1-800-270-4737 to contact us. We will make a determination on your request for reasonable accommodation on a case-by-case basis.

The law requires PDS Tech, Inc. to post a notice describing the Federal laws prohibiting job discrimination. For information regarding your legal rights and protections, please click on the following links: EEO is the Law and EEO is the Law Supplement

PDS Tech, Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. Please see the Pay Transparency Nondiscrimination Provision for more information.

As a Federal Contractor, PDS Tech, Inc. is required to participate in the E-Verify Program to confirm eligibility to work in the United States.
For information please click on the following link: E-Verify