Also referred to as:
Compliance Documentation Director, Product Regulatory Filing Director
Requirements and Responsibilities
Regulatory Documentation Director plans and directs an organization's regulatory documentation process to ensure compliance with internal and external requirements and standards. Develops policies and standards to ensure a controlled documentation and record retention system. Being a Regulatory Documentation Director coordinates and submits required filings for approvals, notifications, and testing data reporting with government or agency officials. Develops classification systems to compile, maintain, and organize regulatory documents such as applications, submissions, and reports to ensure currentness and accessibility. Additionally, Regulatory Documentation Director requires a bachelor's degree. Typically reports to senior management. The Regulatory Documentation Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be a Regulatory Documentation Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function.
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