Sr. Regulatory Specialist

Job description

THE POSITION: 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: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: 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. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by an employee with a disability, unless such accommodation would cause an undue hardship for EVERSANA. If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources. EXPECTATIONS OF THE JOB: Travel: Occasional travel may be required, less than 20% Hours: 40 Hours per week The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position. An individual in this position must be able to successfully perform the expectations listed above. MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. 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 (e.g. trade certificates, driver’s licenses, professional certifications, etc. required) Technology/Equipment (if applicable, the proficiencies required to perform the job) PREFERRED QUALIFICATIONS: Education: Bachelor’s degree with a life sciences discipline. Experience and/or Training: 1-3 years in a pharmaceutical environment. 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: FL or CA Designated Representative Technology/Equipment: Strong MS Office skills (Outlook, Word, Excel, PowerPoint) 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.