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

• 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.
• Ensure accurate, audit-ready documentation of all facility licenses and supporting materials, including timely availability for regulatory inspections, client requests, and internal reviews.
• 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.
• Maintain regulatory intelligence reporting processes and support the integration of regulatory changes into SOPs, operational controls, and business processes.
• Support distribution and client operations by addressing regulatory inquiries, including customer licensure verification, shipment compliance requirements, and alignment with applicable regulations.
• 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.
• 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

• Bachelor's degree or 1-3 years' experience equivalent.
• 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.

Preferred qualifications

• Bachelor's degree with a life sciences discipline.
• 1-3 years in a pharmaceutical environment.
• FL or CA Designated Representative certification.
• Strong MS Office skills (Outlook, Word, Excel, PowerPoint).
• Basic knowledge of Suspicious Order Monitoring systems.

Schedule & travel

• 40 hours per week.
• Occasional travel required, less than 20%.