Sr. Regulatory Specialist

About the role

The Senior Regulatory Specialist manages regulatory compliance programs, with an emphasis on licensure, regulatory intelligence, controlled substance due diligence, and operational regulatory support within pharmaceutical distribution and 3PL environments.

Responsibilities

• Manage End-to-End Licensing Compliance: Lead the preparation, submission, renewal, and maintenance of all state and federal licenses, including coordination with third-party vendors and internal stakeholders, and validation of corporate officers, designated representatives, and supporting licensure requirements.
• Maintain Licensing Records & Inspection Readiness: Ensure accurate, audit-ready documentation of all facility licenses and supporting materials, including timely availability for regulatory inspections, client requests, and internal reviews.
• Lead Regulatory Intelligence & Impact Assessment: Monitor and interpret regulatory updates from BOP, DOH, FDA, DEA, and industry organizations (e.g., NABP, ASHP, APHA), and assess applicability to operations and compliance programs.
• Drive Regulatory Implementation & Governance: Maintain regulatory intelligence reporting processes and support the integration of regulatory changes into SOPs, operational controls, and business processes.
• Provide Operational Regulatory Support: Support distribution and client operations by addressing regulatory inquiries, including customer licensure verification, shipment compliance requirements, and alignment with applicable regulations.
• Execute Controlled Substance Due Diligence & Monitoring: Conduct risk-based due diligence on customers handling controlled substances, including onboarding and periodic reviews, evaluating licensure, regulatory standing, and business activity, and investigating and escalating suspicious or abnormal orders through monitoring systems.
• Support Controlled Substance Compliance Program Effectiveness: Collaborate cross-functionally to determine appropriate disposition of controlled substance orders, maintain documentation of due diligence decisions, and support continuous improvement of suspicious order monitoring and customer due diligence procedures to ensure alignment with DEA and state requirements.

Qualifications

• Education: Bachelor’s degree or 1-3 years’ experience equivalent.
• Experience and/or Training: Strong problem-solving, risk assessment, and impact analysis abilities. Flexible and able to multitask and prioritize competing demands/workflow. Excellent oral and written communication skills.
• Licenses/Certificates: None required, but FL or CA Designated Representative preferred.
• Technology/Equipment: Strong MS Office skills (Outlook, Word, Excel, PowerPoint) and basic knowledge of Suspicious Order Monitoring systems.

Physical/Mental Demands And Working Environment

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands.

Skills

• Strong problem-solving, risk assessment, and impact analysis abilities.
• Flexible and able to multitask and prioritize competing demands/workflow.
• Excellent oral and written communication skills.
• Strong MS Office skills (Outlook, Word, Excel, PowerPoint).
• Basic knowledge of Suspicious Order Monitoring systems.

Benefits

EVERSANA is committed to providing competitive salaries and benefits for all employees. More information about EVERSANA’s benefits package can be found at eversana.com/careers.