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EVERSANA is a global commercialization services company serving the life sciences industry with 7,000+ employees across 650+ clients. This Senior Regulatory Specialist role manages comprehensive regulatory compliance programs within pharmaceutical distribution and 3PL (third-party logistics) environments.
Key responsibilities include:
• End-to-End Licensing Compliance: Lead preparation, submission, renewal, and maintenance of state and federal licenses for pharmaceutical distribution operations. Coordinate with third-party vendors and internal stakeholders to ensure all corporate officers and designated representatives meet licensure requirements.
• Licensing Records & Inspection Readiness: Maintain audit-ready documentation of facility licenses and supporting materials. Ensure timely availability for regulatory inspections, client requests, and internal reviews.
• Regulatory Intelligence & Impact Assessment: Monitor and interpret regulatory updates from BOP, DOH, FDA, DEA, and industry organizations (NABP, ASHP, APHA). Assess applicability to operations and compliance programs.
• Regulatory Implementation & Governance: Maintain regulatory intelligence reporting processes and support integration of regulatory changes into SOPs and operational controls.
• Operational Regulatory Support: Address regulatory inquiries from distribution and client operations, including customer licensure verification, shipment compliance, and regulatory alignment.
• Controlled Substance Due Diligence: Conduct risk-based due diligence on customers handling controlled substances. Evaluate licensure, regulatory standing, and business activity. Investigate and escalate suspicious or abnormal orders through monitoring systems.
• Compliance Program Effectiveness: Collaborate cross-functionally on controlled substance order disposition, maintain due diligence documentation, and support continuous improvement of suspicious order monitoring procedures.
Minimum qualifications: Bachelor's degree or 1-3 years equivalent experience. Strong problem-solving, risk assessment, and impact analysis abilities. Excellent communication skills and ability to multitask.
Preferred: Bachelor's degree in life sciences discipline, 1-3 years pharmaceutical environment experience, FL or CA Designated Representative certification, proficiency in MS Office and Suspicious Order Monitoring systems.
Travel: Occasional, less than 20%. Full-time, 40 hours/week.
