*REGULATORY & 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 Desai's Pharmacy Inc 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 plan/ policies accordingly for team to adhere it.

· Prepare an action plan regarding customer’s complaints for products or pharmacy services. Plan, Direct and Coordinate activities of an organizations to ensure compliance with Federal and State Ethical and Regulatory Standards.

· Prepare and File required documentation for Standards.

· Maintain Regulatory Knowledge.

· Create spreadsheet and reports, analyze data and sample compliance.

· Read, interpret, summarize, Federal and state regulations/statutes and policies.

· To prepare 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 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 Inventory in pharmacy for continued compliance.

· Prepare and update the inventory reports every six months for Controls and regular medicines/ drugs.

· To prepare updated inventory report for all Class Control substances every odd year and maintain it.

· Keep close look at insurance claims to ensure correct billing practices like billing units, refills, partial fills, Pack size selection, Drug Utilization Review (DUR) and override.

· To fulfill that, do self-audit, create report, and keep eye on reimbursement and cost of medicines.

*Bachelor's Degree is required in **Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science*