Regulatory Counsel


Vacancy ID: 756244   Announcement Number: HHS-FDA-CDER-MP-12-756244   USAJOBS Control Number: 327590500

Social Security Number


Vacancy Identification Number

756244
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

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

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

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9. Languages

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10. Lowest Grade


14

11. Miscellaneous Information

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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

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

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

Read the statements below to determine what options (001 and 002) you are eligible to apply.  You must enter at least one code.

001 - Merit Promotion:  I am eligible to be considered under merit promotion procedures because I am a current r FDA Federal employee working in a permanent competitive service position (You must submit documentation to support your eligibility.)

002 - Noncompetitive: I am eligible to be considered under this specialty code because I am a current FDA Federal employees who currently hold or previously held a Federal competitive position with promotion potential at or above the full performance level listed for this position. (You must submit documentation to support your eligibility for noncompetitive appointment).


 


001 Merit Competitive
002 Noncompetitive

21. Geographic Availability


241450031 Silver Spring, 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. Carefully review the responses below, and select the item that best describes your experience as it pertains to the minimum requirements for this position. You must respond to this question and submit a résumé that clearly describes your related experience to be considered.

A. I have at least one full year of specialized experience (equivalent to the GS-13 grade level or higher in the Federal service) that included providing legal/regulatory advice to others, resolving regulatory issues; ensuring that regulations and policies are consistent with statutory requirements as it relates to drug compliance; and drafting and performing legal/regulatory reviews for enforcement action.
B. My experience is not described in choice A above.

For each of the items below, select the one statement that most accurately describes your experience and capability using the scale below.

A- I have no experience in performing this work behavior.
B- I have limited experience in performing this work behavior. I have had exposure to this work behavior but would require additional guidance, instruction, or experience to perform it at a proficient level.
C- I have experience performing this work behavior across routine or predictable situations with minimal supervision or guidance.
D- I have performed this work behavior independently across a wide range of situations. I have assisted others in carrying out this work behavior. I seek guidance in carrying out this work behavior only in unusually complex situations.
E- I am considered an expert in carrying out this work behavior. I advise and instruct others in carrying out this work behavior on a regular basis. I am consulted by my colleagues and/or superiors to carry out this work behavior in unusually complex situations.

2. Consult on compliance actions related to the Food, Drug, and Cosmetic Act related statutes, regulations and policies.

3. Advise clients on legal issues concerning the regulation of drug products or other complex regulatory programs.

4. Review or write comments on proposed regulations.

5. Conduct legal analyses involving complex statutes, regulations, policies, and procedures.

6. Provide advice on the legal sufficiency and procedural adequacy of proposed policies and initiatives.

7. Advise program offices or private clients on procedures and methods for implementing regulations and policy statements.

8. Develop valid approaches to address compliance issues.

9. Resolve issues concerning the application of regulations and/or laws affecting the operation of a program.

10. Conduct planning and consultation for a program's operations.

11. Provide advice and/or training to journeymen and senior regulatory specialists and/or other professionals.

12. Plan complex assignments and projects related to the program area, policies, strategies and inspection decisions.

13. Conduct presentations on compliance policies and initiatives at professional meetings and conferences.

14. Serve as the subject matter expert and provides guidance on regulatory issues to internal and external stakeholders.

15. Provide recommendations on policy and/or regulatory procedures.

16. Coordinate with scientific and regulatory personnel to ensure regulations/guidance are consistent with legal/regulatory requirements.

17. Prepare legal pleadings, such as affidavits, briefs, motions for summary judgment and dismissal.

18. Draft and review written proposals for regulations and policies produced by a team.

19. Analyze replies to inquiries from internal and external stakeholders on legal/regulatory issues.

20. Are you a current FDA employee serving in a permanent, competitive position?

A. Yes (You must provide SF50 at time of application)
B. No