About the role
Duties
As a Regulatory Counsel, the incumbent will: Develop and revise regulations and guidance, advising on compliance with FDA's Good Guidance Practice regulations and other legal/regulatory issues. Provide technical guidance on procedures and methods involved in implementing new programs, guidance, and regulations. Inform management and staff on new or revised regulations, internal policies and procedures, and trends in the pharmaceutical and health care industry. Draft/review proposals for new regulations and policy statements.
Qualifications
In order to qualify for Regulatory Counsel, GS-0301/13, you must meet the following: Have one full year of specialized experience equivalent to the GS-12 grade level or higher in the Federal service handling regulatory issues (i.e. in a firm, regulated industry, or government setting) involving one or more areas: food and drug, healthcare, environmental, or other technical regulatory programs that included analyzing and evaluating complex regulatory activities, processes, policies, and issues.
Education
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