Eversana1
Sr. Regulatory Specialist
Memphis, TN, United States · Senior
Sponsorship not specifiedDetected 9 hours ago
ComplianceExcelFDA RegulatoryCommunicationProblem SolvingMicrosoft Office
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odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Our employees are tasked with delivering excellent business results through the efforts of their teams.
- 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.
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
- Lead Regulatory Intelligence & Impact Assessment
- 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.
- Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them.
- We are deliberate and self-reflective about the kind of team and culture we are building.
Requirements
- Licenses/Certificates (e.g. trade certificates, driver's licenses, professional certifications, etc. required)
- Technology/Equipment (if applicable, the proficiencies required to perform the job)
- Travel: Occasional travel may be required, less than 20%
- An individual in this position must be able to successfully perform the expectations listed above.
Nice to have
- Experience and/or Training:
- 1-3 years in a pharmaceutical environment.
- Strong problem-solving, risk assessment, and impact analysis abilities.
- Licenses/Certificates: FL or CA Designated Representative
- Technology/Equipment:
- Strong MS Office skills (Outlook, Word, Excel, PowerPoint)
- Basic knowledge of Suspicious Order Monitoring systems.
- 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.
Skills
- The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
- Bachelor's degree or 1-3 years' experience equivalent.
- Excellent oral and written communication skills.
Benefits
- We're fueled by our vision to create a healthier world.
- Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry.
- Flexible and able to multitask and prioritize competing demands/workflow.
Company info
- At EVERSANA, we are proud to be certified as a Great Place to Work across the globe.
- Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry.
- We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies.
- 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.
- We are EVERSANA.
Equal opportunity
- If reasonable accommodation is needed to perform the essential functions of your job position, please contact Human Resources.
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This listing is sourced directly from Eversana1's careers page and normalized into a canonical job model.