The incumbent of this position serves as a regulations and regulatory policy analyst in the Office of Regulatory Affairs (ORA). The incumbent assumes primary responsibility for ensuring that regulations and policies developed in the assigned areas are consistent with statutory requirements and existing policy, their need is justified, and that adequate scientific and medical reviews have been completed.
At the full performance level, the incumbent performs duties that include resolving a broad range of issues concerning the application of any of FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government. Assignments involve researching regulatory issues and revising existing or creating new policies and regulations. Major duties include:
Develops policies and programs involving complex and high priority matters affecting the all program areas within regulation of the Offices program responsibility. Drafts or critically reviews documents embodying policy and program proposals and decisions on these products.
· Serves as a regulatory expert in matters related to his/her area of responsibility and is frequently called on to advise others, both internal and external to FDA, concerning FDA statutes, regulation, and policy.
Drafts or reviews proposals for new regulations and policy statements involving his or her area of regulatory expertise. These regulations and policy statements often result from the need to implement new legislation or from new interpretations of existing legislation.
Reviews, summarizes, and drafts responses to all public comments received on proposed regulations; recommends adoption or rejection of counter-proposals contained in comments and objections; drafts final regulations.
Reviews petitions raising issues that affect a segment of the regulated industry as well as those that pertain to the marketing status of individual products. Develops a course of action and drafts responses to such petitions.
Prepares replies to correspondence from the regulated community and other interested persons on issues that affect one or more portions of the regulated industry are industry-wide in scope or have broad health implications and that concern precedent setting interpretations of FDA policy.
· May make presentations at conferences and professional meetings before the regulated industry, clinical investigators, and the medical/scientific community on the applicable regulations and policies.
Duties at the trainee levels will be selected by the supervisor and will be developmental in nature.