Regulatory and Compliance Analyst Job

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

• Implement and oversee compliance with federal and state regulations including DEA, FDA, HIPAA, CMS, and the New York Board of Pharmacy. Submit mandatory reports through PMP (I-STOP), manage controlled substance inventory, and assist in policy creation to improve regulatory efficiency.
• Prepare, compile, and send regulatory documents for FDA, DEA, and State Board compliance.
• Monitor changes in regulatory guidelines and communicate relevant updates to internal staff.
• Draft and review SOPs and regulatory standard documents.
• Participate in audits and inspections by providing necessary documentation and regulatory justifications.
• Prepare monthly reports on regulatory activities and status updates for executive review.
• Review insurance claims including Medicare Part B/D, third-party reimbursements, and perform audits to detect and correct payment discrepancies. Analyze claim submissions and ensure billing code accuracy. Generate cost-efficiency reports for financial optimization.
• Review Medicare Part B/D claims and third-party payer submissions for accuracy, adherence to federal and payer-specific guidelines.
• Prepare quarterly compliance reports summarizing audit outcomes and regulatory violations for leadership review.
• Collaborate with finance and billing departments to implement corrective billing strategies based on audit findings.
• Conduct internal compliance audits and readiness checks to ensure proper documentation, dispensing logs, and inventory align with DEA regulations. Train staff on audit preparation, conduct spot checks, and identify non-compliance issues.
• Maintain exact patient medication records, verify data entries, and assist with applications for pharmacy accreditations like URAC, CPPA, and ACHC. Support data integrity in prescription validation and accreditation processes.
• Conduct scheduled and unscheduled internal audits to evaluate adherence to DEA, FDA, and state pharmacy regulations.
• Create data summaries and charts for quality performance metrics relevant to accreditation benchmarks.
• Coordinate with accreditation bodies and internal compliance teams to submit required documents and address feedback.
• Maintain accurate and HIPAA-compliant digital medication records, ensuring updates align with prescription and patient data changes.
• Track licensing renewals, REMS/iPledge certifications, and implement continuing education and quality improvement programs for pharmacy staff. Conduct mock inspections and coordinate with regulatory agencies for compliance assurance.
• Track pharmacy and pharmacist license renewals across federal, state, and local boards to ensure continuous operational compliance.
• Maintain an active compliance calendar for REMS (Risk Evaluation and Mitigation Strategies) and iPledge certifications, monitoring renewal deadlines and documentation status.
• Implement onboarding compliance training for new hires covering DEA guidelines, REMS protocols, and internal audit standards.
• Schedule and monitor continuing education (CE) requirements for pharmacy staff, ensuring fulfillment of state-mandated CE hours.

Bachelor Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutics or Pharmaceutical Science or Doctor of Pharmacy