What are the responsibilities and job description for the SCSUS Regulatory Specialist position at Sharp Corporation?
Summary
The Regulatory Specialist acts as a liaison between the Sharp organization and the state, local, federal, and international agencies to submit required forms and paperwork as required for controlled substances and licensing activities. The Regulatory Specialist is responsible for organization and coordination of the logistical activities and associated documentation related to the end to end controlled substance supply chain activities at Sharp Clinical on behalf of its clients.
Essential Duties and Responsibilities
- Oversee activity of controlled substances, including overall management of DEA 222 documentation for all inbound / outbound shipments.
- Research, monitor and reports on regulatory activity in assigned states / countries to support projects and client licensing needs
- File the regulatory documents or any other associated documents to FDA, DEA, and other regulatory agencies.
- Apply new license or renew the license of manufacturer, wholesaler, distributor with State Department of Health and other affiliates.
- Support Project Management teams as Subject Matter Expert (SME) for controlled substances to ensure proper management of client study needs.
- Complete and maintain controlled substance shipment records, ensuring compliance with all applicable regulations.
- Analyze complex regulation and quickly compose concise summaries following precise writing standards.
- Research specific regulatory compliance requirements in support of client programs
- Manage Procurement Quota. Includes direct interaction with customers and Project Management to determine required Procurement Quota, completion and submission of Procurement Quota Applications, tracking of available Procurement Quota and completion and submission of Year End Reports, in conjunction and collaboration with Quality Assurance.
- Coordinate returns of controlled substances. Includes maintenance and tracking of DEA 222 Forms, direct interaction with customers and clinical sites, and completion and maintenance of receiving records.
- Support Logistics with USDA Import permits
- Completion and submission of ARCOS reports, includes completing of ARCOS reports utilizing ARCOS PC field edit application.
- Oversee performance Controlled Substance Inventory
- Includes physical inventory and reconciliation of all items to ensure full accountability.
- Maintain working knowledge of current registration status, including controlled substance schedules and Drug Codes. Includes the ability to determine internal capabilities with regards to controlled substance projects.
- Hosting DEA and assist in other relevant regulatory Inspections. Includes presentation of controlled substance records, explanation of processes, and escorting DEA Agents during tours and inventory activities, as needed
- Achieve expected key performance measures.
- Other duties as assigned.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.
