Overview
Join our team as a Regulatory and Compliance Analyst, where you will play a vital role in ensuring our processes meet stringent regulatory standards and quality benchmarks. This position offers an exciting opportunity to work at the forefront of compliance management. Your expertise will help uphold our commitment to safety, efficacy, and regulatory excellence across all operational facets.
Duties
- Ensure day-to-day corporate and pharmacy compliance with FDA, DEA, HIPAA, and state pharmacy board regulations. Identify compliance gaps and maintain mandatory regulatory records and official documentation.
- Maintain prescription, controlled substance, and restricted inventory records in strict accordance with federal and state tracking regulations. Audit enterprise databases to prevent cross-contamination or structural compliance failures.
- Support daily pharmacy operations and real-world workflow management to ensure efficient, legal, and compliant operational pipelines. Document deviations and map structural bottlenecks.
- Assist team leaders in preparing special emphasis audit sections, health authority inspections, localized compliance reviews, and structuring mandatory corrective and preventive action (CAPA) activities.
- Monitor medication storage environmental conditions, inventory levels, and expiration-date tracking. Analyze technical specifications and validation protocols to ensure chemical/biological integrity.
- Maintain Standard Operating Procedures (SOPs), corporate regulatory documentation, and automated document-control systems utilizing specialized software.
- Generate detailed compliance reports, analyze quantitative operational data metrics, and support data-driven management decision-making using advanced spreadsheets and pharmacy software.
Qualifications
- Bachelor's Degree is required in Drug Regulatory Affairs or Pharmaceutical Science or Pharmacy
- Demonstrated ability to manage multiple projects simultaneously with excellent organizational skills
- Excellent research skills with the ability to interpret complex technical information into clear documentation
- Effective communication skills to collaborate across departments and prepare detailed reports on compliance status
This role is ideal for motivated professionals eager to make a tangible impact on operational safety and regulatory excellence. We are committed to fostering an inclusive environment where your expertise can thrive while supporting your professional growth.
Pay: $80,600.00 per year
Benefits:
- Health insurance
- Paid time off
Work Location: In person
