Also referred to as:
Compliance Documentation Manager, Product Regulatory Filing Manager
Requirements and Responsibilities
Regulatory Documentation Manager manages an organization's regulatory documentation process to ensure compliance with internal and external requirements and standards. Monitors and evaluates processes and procedures to ensure a controlled documentation and record retention system. Being a Regulatory Documentation Manager reviews and validates required filings for approvals, notifications, and testing data reporting with government or agency officials. Implements and improves classification systems to compile, maintain, and organize regulatory documents such as applications, submissions, and reports to ensure currentness and accessibility. Additionally, Regulatory Documentation Manager requires a bachelor's degree. Typically reports to a director. The Regulatory Documentation Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Documentation Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes.
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