The purpose of this position is to enforce the laws and regulations protecting consumers from foods, feed and medical products and tobacco products that are misbranded, adulterated or in some other way dangerous, or defective. The position can also involve the development of policy, regulations, and process that are implemented in the Food and Drug Administration (FDA). At the full performance level, major duties include:
· Develops, monitors, coordinates, and implements Agency policies and initiatives related to FDA regulated products.
· Initiates necessary action and interaction between the Office of Regulatory Affairs (ORA) and other FDA components in developing and agreeing upon Agency positions and decisions. This includes preparation of background materials on programs and policies for presentation and/or use in briefings and other meetings.
· Serves as a recognized authority in matters related to his or her area of expertise and responsibility (such as: Human Food, Animal Feed, Human Drugs, Animal Drugs, Biologics, Medical Devices, Tobacco Products, or other major regulatory functional area) and is frequently called on to advise others concerning FDA statutes, regulations and controversial policy issues affecting FDA programs and activities.
· Maintains a knowledge and awareness of the organization's objectives and exercises analytical judgment to anticipate potential problems and sensitive issues that may arise. Drafts or reviews proposals for new regulations and policy statements involving his or her area of expertise.
· Prepares replies to correspondence from the regulated community and other interested persons on issues that are industry-wide in scope or have broad health implications and that concern precedent setting interpretations of FDA policy.
· Reviews, summarizes, and drafts responses to public comments received on proposed regulations; recommends adoption or rejection of counter-proposals contained in comments and objections; drafts final regulations.
· Develops, recommends, and implements ORA compliance policies and procedures designed to ensure consistency and balance throughout ORA and in agency-wide programs involving other Federal, State, Local, and/or Foreign government counterparts.