Regulatory and Compliance Analyst Job

Regulatory and Compliance Analyst is needed to perform the following duties:

• Coordinate and document Internal Regulatory processes such as Internal Audits, Registrations, License Renewals, and Inspections:
• Ensure that Pharmacy is compliant with the federal Controlled Substances act (CSA) for their Storage, labeling, and dispensing practices, prepared for demonstrating their compliance in the event of a U. S. Drug Enforcement Administration (DEA) inspection or investigation.
• To obtain new licenses, renew it in advance, certifications, registrations, and exemptions.
• According to current rules and regulations, review and update internal policies and SOP (Standard Operating Procedure).
• Document and maintain compliance reports related to virtual or on-site Audits, Internal Inspections, and other initiative as needed.
• Identify non compliance areas and prepare action plans/ policies accordingly for the team to adhere it.
• Prepare an action plan regarding customer’s complaints for products or pharmacy services
• Plan, Direct and Coordinate activities of an organization to ensure compliance with Federal and State Ethical and Regulatory Standards.
• Prepare and File required documentation for Standards.
• Maintain Regulatory Knowledge.
• Create spreadsheets and reports, analyze data and sample compliance.
• Read, interpret, summarize, Federal and state regulations/ statutes and policies.
• To prepare a report for any Regulatory essential submission and plan of action in pharmacy.
• Ensure and maintain daily duties, which are all class control drugs reporting to the state through Pharmacy management software system or through website.
• CIR (City Immunization Registry) and SMP (Scripts Management Partners) reporting.
• OTC Network, Credit Card, and Gift card compliance as per standard
• Monitor quality and compliance regulations impacting overall drugs Inventory operations
• Identify the appropriate action to arrange the strokes in pharmacy for continued compliance.
• Prepare and update the inventory reports every six months for Controls and regular medicines/ drugs.
• To prepare an updated inventory report for all Class Control substances every odd year and maintain it.
• Keep a close look at insurance claims to ensure correct billing practices like billing units,refills, partial fills, Packsize Selection, Drug Utilization Review (DUR) and override.
• To fulfill that, do self-audit, create reports, and keep eye on reimbursement and cost of medicines.

Bachelor’s degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutics or Pharmaceutical Science or Doctor of Pharmacy