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Regulatory Affairs Director oversees all 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 top management. The Regulatory Affairs 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 Affairs Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function.
Product Regulatory Director directs the teams and processes that ensure new and existing products comply with internal and external regulations and standards. Analyzes regulatory requirements to develop internal processes and standards that comply with external regulations. Being a Product Regulatory Director develops policies and procedures to prepare required filings for approvals, notifications, and testing data reporting in compliance with regulatory requirements. Researches and plans regulatory changes to reduce the impacts of compliance on the organization. Additionally, Product Regulatory Director remains up to date on industry trends and best practices for testing processes, labeling standards, and technical literature for legal or marketing. Liaises with regulatory agencies to address complex questions, provide additional information, or resolve issues with submissions. Requires a bachelor's degree. Typically reports to senior management. The Product Regulatory 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 Product Regulatory Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function.
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.
Regulatory Auditing Director oversees all aspects of an organization's auditing strategy and activities for regulatory compliance. Leads the development and implementation of internal controls, best practices and strategies to identify process deficiencies and implement improvements. Being a Regulatory Auditing Director prepares for and participates in external regulatory inspections and internal audits. Ensures that all required regulatory reporting meets content and scheduling requirements. Additionally, Regulatory Auditing Director incorporates document reviews, protocol reviews, validation reviews, and training programs as part of auditing processes. Maintains an up-to-date and in-depth knowledge base of the financial regulations, required processes, and industry/regulatory agency standards that govern a business or a product. Requires a bachelor's degree. Typically reports to top management. The Regulatory Auditing Director manages a departmental function within a broader corporate function. Develops major goals to support broad functional objectives. Approves policies developed within various sub-functions and departments. To be a Regulatory Auditing Director typically requires 8+ years of managerial experience. Comprehensive knowledge of the overall departmental function.