Summary
This position is located in the Human Foods Program (HFP) Nutrition Center of Excellence (NCE), Division of Infant Formula Pre-Market Review (DIFPR), with the mission to protect and promote the health and wellness of people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease and ensure chemicals in food are safe.
Duties
Review Infant Formula Premarket Submissions Reviews and evaluates new infant formula premarket notifications and before-first-processing submissions submitted by industry
Examines submissions for completeness, scientific adequacy, and compliance with the Infant Formula Act of 1980 and applicable FDA regulations.
Coordinates with scientific reviewers across HFP offices to establish review timelines and ensure complete, timely agency responses.
Assists with training new COFS personnel on application procedures.
Receives and responds to inquiries from a wide range of stakeholders, including manufacturers, trade associations, legal representatives, other Federal agencies, and State and foreign governments.
Assists with development of written responses to general correspondence, handles phone inquiries, and coordinates oral and written responses to both routine and complex regulatory questions related to infant formula and medical foods.
Uses the DIFPR database and other automated systems to maintain the administrative record for infant formula submissions, GRAS notices, FOIA requests, and export certificates.
Education
There is no education substitution for this at the GS-12 and above grade level. EDUCATION: 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. 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 https://sites.ed.gov/international/recognition-of-foreign-qualifications/
How you will be evaluated
You must meet the requirements of the job by 11:59 (Eastern Standard Time) of the closing date: 10/12/2026 Your eligibility for consideration and qualifications for the position (as listed in this vacancy announcement above) will be evaluated based on your application materials (e.g., resume, supporting documents) and your score from the required assessment(s). The application review process will be conducted in multiple stages: Eligibility Consideration: Once the application process is complete, the Human Resources Office will review your application and supporting documentation to determine it is complete, meets the two (2) page resume limit and meets the eligibility requirements for this vacancy. Minimum Qualifications: Then, the Human Resources Office will review your resume and supporting documentation to determine whether you meet the minimum job requirements and qualifications. Assessment and Rating Process: This vacancy will use the following assessment(s): Structured Resume Review Next, the Human Resources Office and/or Subject Matter Experts (SMEs) will review your technical qualifications based on the extent and quality of your experience, education (if applicable to the job), and training described in your resume, questionnaire, and assessment documentation as related to the duties and competencies of this position. You will be assessed on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these competencies. Technical Competence Planning and Evaluating Written Communication Oral Communication This assessment and rating process will determine your quality category for referral. Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration or your score may be adjusted to more accurately reflect your skills and abilities. All qualified Non-Competitive applicants and the best-qualified applicants will be referred to the hiring manager for consideration. Career Transition Assistance Programs: Employees who have been involuntarily separated from a Federal service position within the competitive service or whose positions have been deemed surplus or no longer needed. To receive selection priority, you must: 1) meet CTAP or ICTAP eligibility criteria; 2) be rated well-qualified for the position (obtain a score of 85 or higher on assessments); and 3) submit the appropriate documentation to support your CTAP or ICTAP eligibility. Referral Consideration: If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview, review of requested work samples, etc. Failure to comply with any of the additional assessment requirements will result in removal from further consideration.