Also referred to as: Associate Director - Regulatory Affairs, Manager of Regulatory Affairs and Compliance, Regulatory Filings and Process Manager
Requirements and Responsibilities

Regulatory Affairs Manager oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance. Being a Regulatory Affairs Manager requires a bachelor's degree in area of specialty. Typically reports to top management. 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. Extensive knowledge of department processes. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 to 3 years supervisory experience may be required.

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