The Product Regulatory Affairs Manager analyzes regulatory requirements and audits project designs, plans, and processes to monitor compliance with current or upcoming regulations. Manages the teams and processes that ensure new and existing products comply with internal and external regulations and standards. Being a Product Regulatory Affairs Manager manages and navigates regulatory changes to reduce the impacts of compliance on the organization. Implements policies and procedures to prepare required filings for approvals, notifications, and testing data reporting in compliance with regulatory requirements. In addition, Product Regulatory Affairs Manager 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 questions, provide additional information, or resolve issues with submissions. Requires a bachelor's degree. Typically reports to a director. The Product 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. Working as a Product 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 Affairs Supervisor analyzes regulatory requirements and audits project designs, plans, and processes to monitor compliance with current or upcoming regulations. Oversees the processes that ensure new and existing products comply with internal and external regulations and standards. Being a Product Regulatory Affairs Supervisor collaborates with product teams to coordinate regulatory changes and support compliance actions. Prepares and reviews required filings for approvals, notifications, and testing data reporting to ensure quality and correctness of filings in content, format, and timing requirements. In addition, Product Regulatory Affairs Supervisor researches industry trends and recommends improvements for testing processes, labeling standards, and technical literature for legal or marketing. Liaises with regulatory agencies to address questions or provide additional information. Requires a bachelor's degree. Typically reports to a manager. The Product Regulatory Affairs Supervisor supervises a group of primarily para-professional level staffs. May also be a level above a supervisor within high volume administrative/production environments. Makes day-to-day decisions within or for a group/small department. Has some authority for personnel actions. Working as a Product Regulatory Affairs Supervisor typically requires 3-5 years experience in the related area as an individual contributor. Thorough knowledge of functional area and department processes.
The Product Regulatory Affairs Senior Manager analyzes regulatory requirements and audits project designs, plans, and processes to monitor compliance with current or upcoming regulations. Manages the teams and processes that ensure new and existing products comply with internal and external regulations and standards. Being a Product Regulatory Affairs Senior Manager manages and navigates regulatory changes to reduce the impacts of compliance on the organization. Implements policies and procedures to prepare required filings for approvals, notifications, and testing data reporting in compliance with regulatory requirements. In addition, Product Regulatory Affairs Senior Manager 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 questions, provide additional information, or resolve issues with submissions. Requires a bachelor's degree. Typically reports to a director. The Product Regulatory Affairs 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 Product Regulatory Affairs Senior Manager typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments.
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.
Government Affairs Manager implements strategic plans and oversees engagement objectives to develop and maintain productive relations with all levels of government authorities that will support and enhance the businesses' goals. Manages teams that build relationships and liaise with government entities(federal, state, provincial, or local) that regulate or influence business activities. Being a Government Affairs Manager performs ongoing monitoring and analysis of proposed legislation, emerging issues, and trends to determine the potential impact on the organization. Collaborates with industry groups and organizations with complementary objectives to achieve objectives. Additionally, Government Affairs Manager creates communication vehicles and delivers messaging to inform and support business leaders. Requires a bachelor's degree in public policy, public administration, business or equivalent. Typically reports to a director. The Government 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 Government 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.