Also referred to as:
Compliance Documentation Specialist V, Product Regulatory Filing Specialist V
Requirements and Responsibilities
Regulatory Documentation Specialist V prepares and maintains regulatory documents to ensure compliance with internal and external requirements and standards. Follows organizational policies and procedures to ensure a controlled documentation and record retention system. Being a Regulatory Documentation Specialist V maintains, records, and communicates technical and non-technical documentation changes. Prepares required filings for approvals, notifications, and testing data reporting with government or agency officials. Additionally, Regulatory Documentation Specialist V compiles, maintains, and organizes regulatory documents such as applications, submissions, and reports to ensure currentness and accessibility. Requires a bachelor's degree. Typically reports to a manager. The Regulatory Documentation Specialist V works autonomously. Goals are generally communicated in "solution" or project goal terms. May provide a leadership role for the work group through knowledge in the area of specialization. Works on advanced, complex technical projects or business issues requiring state of the art technical or industry knowledge. To be a Regulatory Documentation Specialist V typically requires 10+ years of related experience.
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