The Regulatory Filings and Process Senior Manager develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Being a Regulatory Filings and Process Senior Manager anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Establishes monitoring policies and procedures to ensure compliance with existing regulations. In addition, Regulatory Filings and Process Senior Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Filings and Process Senior Manager 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. Working as a Regulatory Filings and Process Senior Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments.
The Regulatory Filings and Process Manager coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance. Oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Being a Regulatory Filings and Process Manager typically reports to top management. Requires a bachelor's degree in area of specialty. The Regulatory Filings and Process 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. Extensive knowledge of department processes. Working as a Regulatory Filings and Process Manager typically requires 5 years experience in the related area as an individual contributor. 1 to 3 years supervisory experience may be required.
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 Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established 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 Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs 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 Affairs 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.
The Product Regulatory Filing Director develops policies and standards to ensure a controlled documentation and record retention system. Plans and directs an organization's regulatory documentation process to ensure compliance with internal and external requirements and standards. Being a Product Regulatory Filing Director develops classification systems to compile, maintain, and organize regulatory documents such as applications, submissions, and reports to ensure currentness and accessibility. Coordinates and submits required filings for approvals, notifications, and testing data reporting with government or agency officials. In addition, Product Regulatory Filing Director requires a bachelor's degree. Typically reports to senior management. The Product Regulatory Filing 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. Working as a Product Regulatory Filing Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function.