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.
Documenting experience:
In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description.
Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment.
The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed.
It is expected that this documentation is included in the employee's official personnel record.
In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.
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