Regulatory Counsel - Center for Drug Evaluation and Research, U.S. Dep't of Health and Human Services

See full job posting here.

Job Title:Regulatory Counsel, GS-301-13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-DE-13-782370

SALARY RANGE:	$89,033.00 to $115,742.00 / Per Year
OPEN PERIOD:	Wednesday, November 06, 2013 to Wednesday, November 20, 2013
SERIES & GRADE:	GS-0301-13
POSITION INFORMATION:	Full Time - Permanent
PROMOTION POTENTIAL: 13
DUTY LOCATIONS:	Many vacancies in the following location: Silver Spring, MD View Map
WHO MAY APPLY:	United States Citizens

JOB SUMMARY:

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

These positions are located in various divisions such as: Division of Compliance Risk Management & Surveillance, Division of Manufacturing & Product Quality, and Division of Scientific Investigations, within the Center for Drug Evaluation and Research (CDER).  The incumbent will be responsible for independent legal/regulatory analysis to determine if policies are consistent with statutory requirements and existing program policies.

This job opportunity announcement may be used to fill multiple vacancies.

KEY REQUIREMENTS

• U.S Citizenship
• Suitability for Federal employment determined by background investigation
• May be required to serve a one-year probationary period

---

DUTIES:

Back to top

• Provides expert legal advice on FDA statutes and regulations.
• Conducts analyses of complex legal and policy issues to advise staff in the FDA's Center for Drug Evaluation and Research in carrying out its regulatory mission.
• Prepares replies to correspondence from the regulated community, members of Congress, and other interested persons on legal/regulatory issues.
• Reviews and drafts comments on new regulations and/or interpretations of existing legistlation.
• Provides advice and guidance to regulatory specialists and other professionals within FDA.

---

QUALIFICATIONS REQUIRED:

Back to top

To qualify for the GS-13, you must have at least one year of specialized experience equivalent to the GS-12 in the Federal service that included interpreting and applying FDA statutes and regulations; drafting policies, regulations, and guidance for a regulated program; preparing correspondence based on inquiries regarding program regulatory issues; and providing legal advice on regulations and statutes of a program.

. . . 

HOW TO APPLY:

Back to top

Click the Apply Online button to create an account or log in to your existing USAJOBS account.  Follow the prompts to complete the on-line assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.

Note: To return to your saved application materials, log in at: https://applicationmanager.gov/ and click on 782370.

If you cannot apply online, you will need to:

1) Print the instructions and questionnaire by clicking View Occupational Questionnaire.

2) Print the 1203FX form to record your responses to the questionnaire.

3) Fax the completed 1203FX (all 6 pages but do not include a Cover Page for this document) to:  1-478-757-3144.

4) Print the Fax Cover Pageand include with any supporting documents you fax (e.g., résumé, transcripts, veterans documentation, etc.) to the same fax number above.

Please do not complete steps 1-4 above if you are applying on-line.

REQUIRED DOCUMENTS:

• Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.
• Responses to the Assessment Questionnaire

Other Supporting Documents: (Only submit if applicable to you.)

• Veterans' Preference documentation (i.e. SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc. ) 
• CTAP/ICTAP documentation

APPLICATION MATERIALS MUST BE RECEIVED BY MIDNIGHT (EASTERN TIME) ON THE CLOSING DATE OF THIS ANNOUNCEMENT

For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc

AGENCY CONTACT INFO:

Mid-Atlantic Services Branch
Phone: (757)441-6765
Email: NORFOLKMAIL@OPM.GOV

Agency Information:
HHS OPM
1900 E St NW
Washington, DC
20415