Regulatory Counsel

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

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