Regulatory & Compliance Analysts need to perform the following duties:

· Coordinate and document Internal Regulatory processes such as Internal Audits, Registrations, License Renewal, and Inspections.

· Plan, Direct, and Coordinate activities of an Organization to ensure compliance with Federal and State Ethical and Regulatory Standards.

· Develop, Implement, and Enforce policies & Stored procedures that keep a company’s products, processes, and physical sites operating in a legal & ethical manner.

· Create spreadsheets and reports, analyze data, and sample for compliance

· Verify Prescriptions for correct drug name, strength, direction, DAW Codes, date is written, Prescriber name, and associated NPI/DEA and to make sure all state and federal prescription requirements are met

· Updating Inventories for regular and controlled medicines every 6 months and assisting in returning the medications in a legal way

· Help uncover unnecessary costs to the insurance system by taking a close look at billing practices that include billing units, refill practices, overrides, partial fill procedures, package size selection, and proof of documentation. If the following self-audit steps reveal potential overpayments, the self–audit guidelines explain the steps that must be followed.

· Monitor and Evaluate FDA enforcement activities including 483s, warning letters and EIRs (Establishment Inspection report)

· Monitor quality and compliance regulations impacting overall stokes operations to quickly identify appropriate actions to take to position stokes pharmacy for continued compliance

· Serve as a resource for all external third-party payer audits, gathering information, as appropriate, to ensure prompt and enough response.

Bachelor’s Degree required in Drug regulatory affairs or Public Administration or Pharmacy or Pharmaceutical Science or Pharmaceutics