Regulatory Counsel


Vacancy ID: 780039   Announcement Number: HHS-FDA-CTP-MP-13-780039   USAJOBS Control Number: 330382700

Social Security Number

Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name.  As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

Enter 780039
1. Title of Job

Regulatory Counsel
2. Biographic Data

3. E-Mail Address

4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

Are you an ICTAP Eligible?

For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.


Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?


Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.    


Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)    


Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?


Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers.  This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.


6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 13.


13

11. Miscellaneous Information

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Select/enter at least one occupational specialty. The specialty code for this position is:


001 Regulatory Counsel

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


241360031 Rockville, MD

22. Transition Assistance Plan

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

1. From the descriptions below, select the one response which best describes your experience which meet the Qualification Requirements for Regulatory Counsel, GS-0301-13.

A. I have one year of specialized experience, equivalent to the GS-12 grade level in the Federal service, to include experience planning analysis or researching issues in support of programs; drafting legal documents; drafting and/or commenting on proposed policy or reviewing and drafting regulations and guidance documents.
B. I do not possess the experience described above.

In this section, you are asked to evaluate yourself on task items using the scale provided. When marking your ratings, please do not overstate or understate your level of experience or capability. You should be aware that your ratings are subject to evaluation and verification. Do not give yourself credit for having performed tasks you have not performed. Additional steps in the selection process are designed to verify your stated level of experience and capability. Deliberate attempts to falsify information will be grounds for not selecting you or for dismissing you from employment with the organization.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or is normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

2. Develop policies involving matters affecting regulated products.

3. Implement new laws and regulations that impact the mission of the organization.

4. Interpret and adapt program and policy objectives.

5. Conduct research into legal precedents and legislative history of the laws enforced by FDA or other federal/state agencies.

6. Evaluate the impact of existing laws and new or revised legislation and regulations.

7. Use resources such as Westlaw, LexisNexis, MediRegs, the US Code of Federal Regulations, the Federal Register, and others, to conduct legal research regarding established precedents in order to develop and support legally sufficient documents.

8. Establish and maintain cooperative relationships with high level officials within the organization.

9. Provide guidance and consultation to other offices within the organization on the laws and regulations enforced by a regulatory agency.

10. Contribute to working groups of scientific, regulatory and legal experts to develop policy recommendations.

11. Make oral presentations to recommend changes to programs and procedures to management officials and major stakeholders within the organization at different levels to work on issues, goals and objectives.

12. Serve as an agency representative in conferences, meetings and workshops with regulated industry, major stakeholders and other government agencies.

13. Make oral presentations on regulations and guidance documents for high level officials within the organization and in other regulatory agencies.

14. Draft or critically review documents embodying policy and program proposals and decisions on products.

15. Prepare replies to correspondence from the regulated community and other interested persons on issues that affect one or more portions of the regulated industry.

16. Prepare recommendations to resolve complex legal or compliance issues.