Regulatory specialist

Summary This position is located in the Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), which utilizes quality controlled, computer based information systems covering the registration of establishments and listing of human-cell, tissue and tissue-based products.

Responsibilities Prepares analysis of regulatory information / data needs for assigned information of the office to identify existing capabilities for providing information to management.

Validates information in the system for accuracy and completeness and tracks regulatory actions pertaining to submissions reviewed with the Division.

Coordinates enhancements to the Center’s data information systems which pertain to the assigned products regulated by the Office.

Explains reporting capabilities of the systems and meaning of reports generated based on experience with both reports and systems.

Requirements Conditions of Employment Qualifications The position of Regulatory Information Specialist falls within the 0301 occupational series.

To qualify for this position at grade GS-9, you must meet Time-in-Grade requirements by 11 : 59 pm EST on 03 / 06 / 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 : In order to qualify for the GS-09, applicants must have one (1)year of specialized experience, equivalent to at least the GS-07 grade level in the Federal service which includes : (1) Gathering information from biological products and from their establishments for regulatory review;

OR (2) Validating information in the system for accuracy and completeness; OR (3) Creating and providing data based reports to senior staff members.

OR In lieu of specialized experience, you must have a master's or equivalent graduate degree; two (2) full years of progressively higher-level graduate education leading to such a degree;

LL.B. or J.D., 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.

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, , 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.

Your uploaded documents may take several hours to clear the virus scan process. 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 internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series / grade in question.

See the Required Documents section for full details... Education EDUCATION : THIS POSITION DOES NOT HAVE AN EDUCATIONAL REQUIREMENT.

TRANSCRIPTS : Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required.

Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. Electronic Transcript Caution : If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file.

Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript.

If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

See the Application Manager Documentation for tips on submitting your paper-based documents. FOREIGN EDUCATION Applicants using part, or all of their education completed outside of the U.

S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.

• S. We will only accept the completed foreign credential evaluation. To be acceptable, the foreign credential evaluation must include / describe at a minimum, the following information : (1) The type of education received by the applicant;
• 2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council;
• 3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system;

and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.

Note : Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and / or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below : National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation Additional Information ADDITIONAL CONDITIONS OF EMPLOYMENT : Pre-employment physical required : NO Drug testing required : NO License required : NO Mobility agreement required : NO Immunization required : NO Bargaining Unit : YES - 3591 Financial Disclosure : NO Telework eligible : YES, at the discretion of the supervisor Travel required : NO Background investigation required : YES Ethics Preclearance : NO If you are serving, or have served in the last 5 years (from 03 / 06 / 2024) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS / FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment.

You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed.

If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment.

In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire.

Political Appointees FAQ - OPM This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation.

If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.

For more information please visit the FDA Ethics web page : Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring.

To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.

All requirements must be met by the closing date of this announcement (03 / 06 / 2024); only education and experience gained by this date will be considered.

You must continue to meet all requirements throughout the hiring process. Additional selections may be made within the same geographical area FDA-wide.

Last updated : 2024-03-04