Job Overview

Summary

 

 

 

*****ANNOUNCEMENT IS CANCELLED. THIS IS NOT A TRUE VACANCY.*****   

 

 

 

 

This position is located in the Food and Drug Administration's Center for Drug Evaluation and Research, Office of Regulatory Policy, Silver Spring, MD. 

 

Who May Apply:  Open to all United States Citizens.

This announcement may be used to fill multiple positions.

 

This position is in the Excepted Service.  Appointment does not confer competitive status.

Duties

As an Attorney-Advisor in the Office of Regulatory Policy, you will be engaged in a variety of complex regulatory policy issues pertaining to the regulation of human drugs.  Principal responsibilities are to:

 

  • Conduct legal research regarding established precedents in order to develop and support legally sufficient regulations, citizen petition responses, and policies using Westlaw, LexisNexis, MediRegs, US Code, Code of Federal Regulations, and the Federal Register.  Prepare legal analyses in conjunction with the promulation of proposed rules and final rules.

 

  • Develop policies and programs involving complex and high priority matters affecting the regulation of drug products.  Draft or critically review documents embodying policy and program proposals and decisions on these products, including regulations, citizen petition responses, proposed legislation, and policy statements to ensure they are legally sufficient. 
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  • Lead working groups of scientific, regulatory, and legal experts to develop new or revised regulations and drafts the resulting notices of propsed rulemaking.

 

  • Review, summarize, and draft responses to all public comments received on proposed regulations, recommend adoption or rejection of counter-proposals contained in comments and objections, and draft final regulations.

 

  • Prepare replies to correspondence from the regulated community, Congress, and other interested persons on issues that are industry-wide in scope or have broad health implications and that concern precedent setting interpretations of laws governing FDA and FDA's policy.