Regulatory Information Specialist

The position of Regulatory Information Specialist falls under the 0301 occupational series. To qualify for this position at grade GS-9/11, you must meet Time-in-Grade requirements by 11:59 pm EST on 10/15/2024. Minimum Qualifications: Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. The specialized experience must demonstrate one year of full-time work experience , or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. Specialized Experience for GS-09: Applicants must have one (1) year of specialized experience, equivalent to the GS-07 in the Federal service to include: 1) Verifies integrity and accuracy of information and data in assigned aspects of systems; AND 2) Provides assistance to employees in assigned areas who perform duties involving the data in the system or the products covered by that system; AND 3) Assisting higher level specialists in identifying where information may impact multiple parts of the assigned database systems and how that data needs to interact. -OR- In lieu of specialized experience, applicants must possess a master’s or equivalent graduate degree or 2 full years of progressively higher level graduate education leading to such a degree or LL.B. or J.D., if related. Specialized Experience for GS-11: Applicants must have one (1) year of specialized experience, equivalent to the GS-09 in the Federal service to include: 1) Assisting in managing assigned areas of the regulatory information system that supports product and establishment submissions and licenses regulated of biological products; AND 2) Analyzes regulatory review information/data needs to assigned areas in relation to existing capabilities for providing information to management on topics associated with the regulatory review process and use fee requirements; AND 3) Aiding a variety of users, reviewers, and managers on how to use systems, types of information available, and reporting capabilities. -OR- In lieu of specialized experience, applicants may possess a Ph.D. or equivalent doctoral degree or 3 full years of progressively higher level graduate education leading to such a degree or LL.M., if related. 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. If you are applying based on some other qualifying eligibility (i.e. you are not applying as a current Federal employee), you must meet the specific requirements of the eligibility you are claiming, and must have sufficient past experience to demonstrate that you are minimally qualified for this position. See Unique Hiring Paths on USAJOBS for more information about various ways you may be eligible to apply! PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://secure.login.gov/ select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. You must submit supporting documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying as a Veteran, individual with a qualifying disability, or a displaced employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for details. Be sure that any files you upload as supporting documentation are free of security or compression features which render such documents unreadable to our system.
This position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR), which provides regulatory support for the receipt, processing, and completion of all pre- and post marketing communications and submissions.