Regulatory Counsel -- FDA

To Apply: http://www.fda.gov/AboutFDA/WorkingatFDA/GenericDrugUserFeeHiring/ucm354892.htm Regulatory Counsel FDA - Washington D.C. Metro Area Job Description Description of Duties at GS-13 level: • Conducts analyses of complex legal and policy issues to advise staff in the FDA's Center for Drug Evaluation and Research in carrying out its regulatory mission. • Works with scientific, regulatory, and legal experts to develop policies, regulations, and documents pertaining to the regulation of drug products. • Reviews, drafts, and comments on responses to citizen petitions, regulations, guidances, legislation, pleadings, policy documents, and legal or other correspondence on matters pertaining to FDA's jurisdiction. • Provides advice and guidance to regulatory specialists and other professionals within FDA. Description of duties at GS-14 level: • Conducts sophisticated analyses of complex legal and policy issues to advise staff in the FDA's Center for Drug Evaluation and Research in carrying out its regulatory mission. •Works with scientific, regulatory, and legal experts to develop policies, regulations, and documents pertaining to the regulation of drug products. • Reviews, drafts, and comments on responses to citizen petitions, regulations, guidances, legislation, pleadings, policy documents, and legal or other correspondence on matters pertaining to FDA's jurisdiction. • Provides advice, guidance, and training to more junior Regulatory Counsels, regulatory specialists, and other professionals within FDA. Desired Skills & Experience Key Requirements: U.S. Citizenship Suitability for Federal employment determined by background investigation May be required to serve a one-year probationary period