Basic Qualification Requirements for a Supervisory Regulatory Specialist, GS-401:
Have at least a bachelor's degree with a major in the biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the work of the position from an accredited college or university.
Have a combination of education and experience-Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.
Additional Qualification Requirements for a Supervisory Regulatory Specialist, GS-401-15:
Have one year of specialized experience, equivalent to the GS-14 grade level in the Federal service, managing and directing the coordination, monitoring and reviewing of broad/complex regulatory and quality affairs operations; implementing emergency preparedness and response activities; advising scientist and manufactures on regulatory requirements, external quality systems and on changes to systems and on storage, labeling, and packaging requirements; and managing human resources, financial and budgetary requirements, and administrative and operational matters; experience in the development and acquisition life cycle as it relates to regulated biologics, pharmaceuticals, and device products.
Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov/.
Conditions of Employment:
1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.
2. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
4. All qualification requirements must be met by the closing date of the announcement.
5. Financial disclosure statement is required.
6. One-year probationary period may be required.
7. Bargaining Unit Position: No
8. Drug Screening Required: No
9. Recruitment Bonus may be authorized: Yes
10. Domestic and International travel is required 20%-30% of the time.
11. Relocation incentive may be authorized: Yes
12. Student Loan repayment may be authorized: Yes
13. Annual Leave credit may be authorized: Yes
HOW YOU WILL BE EVALUATED:
Once the application process is complete, a review of resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job. If, after reviewing your resume and or supporting documentation, a determination is made that you have inflated your qualifications and or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility. Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of three categories: Best Qualified, Well Qualified or Qualified.
The Category Rating Process does not add veterans preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher). Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):
1. Knowledge of vaccination regulations to ensure compliance of vaccines and therapeutic acquisitions.
2. Ability to provide day to day operational support to accomplish the division's values and missions.
3. Ability to manage the Division's workload effectively and efficiently.
4. Skill in oral communication.
5. Skill in written communication.
6. Knowledge of the regulations pertaining to biologics, drugs and medical device products.
7. Ability to advise key personnel on regulatory compliance for the development, manufacture and use of therapeutics and vaccines.
8. Knowledge of administrative laws, advanced principles and policies, regulations and precedents as they relate to scientific, technical, medical, public health and regulatory issues.
9. Ability to analyze, evaluate, and resolve any regulatory/quality development issues that could impact the response to Public Health emergencies.