Sr. Regulatory Specialist

Sr. Regulatory Specialist

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.

Essential duties and responsibilities include managing end-to-end licensing compliance, leading 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.

Additionally, the role involves maintaining licensing records and inspection readiness, ensuring accurate, audit-ready documentation of all facility licenses and supporting materials, including timely availability for regulatory inspections, client requests, and internal reviews.

The Senior Regulatory Specialist also leads regulatory intelligence and impact assessment, monitoring and interpreting regulatory updates from BOP, DOH, FDA, DEA, and industry organizations (e.g., NABP, ASHP, APHA), and assessing applicability to operations and compliance programs.

The role drives regulatory implementation and governance, maintaining regulatory intelligence reporting processes and supporting the integration of regulatory changes into SOPs, operational controls, and business processes.

Supporting distribution and client operations by addressing regulatory inquiries, including customer licensure verification, shipment compliance requirements, and alignment with applicable regulations, is also part of the job.

The Senior Regulatory Specialist executes controlled substance due diligence and monitoring, conducting 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.

Collaborating cross-functionally to determine appropriate disposition of controlled substance orders, maintaining documentation of due diligence decisions, and supporting continuous improvement of suspicious order monitoring and customer due diligence procedures to ensure alignment with DEA and state requirements is also required.

Minimum knowledge, skills, and abilities include a 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, and excellent oral and written communication skills.