Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Position Summary:
Prepares, submits and maintains clinical trials regulatory data and documents. Initiates and maintains all Regulatory documents necessary for submission to Institutional Review Boards, study sponsors, and various agencies in order to obtain initial and continued approval of all clinical trials. This position functions as an integral part of a project team whose objective is to assist study sponsors, physicians, and patients enroll and complete clinical research trials. This position is responsible for all regulatory document coordination, filing, monitoring and reporting to the project team regarding regulatory information. The Regulatory Coordinator also receives, processes, distributes, and manages clinical trial safety reporting.
Position Qualification:
Required:
1-3 years experience in clinical, research, and/or regulatory support role.
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