Work as Regulatory Counsel at Center for Biologics Evaluation and Research | US Jobs

CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

Post : Regulatory Counsel

Job Description
Summary
This position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of the Center Director, which is located in Silver Spring, Maryland.

Responsibilities
• Serves as an expert consultant on the regulatory process within the Office of the Center Director and other Offices within the center, and other agency components.
• Develops policies and program involving the most complex and highest priority matters affecting the regulation of biological products and related
• Drafts or critically reviews documents embodying policy and program proposals and decisions on these products.
• Performs duties that include resolving a broad range of issues concerning the application of any of FDA's enabling legislation, pertinent regulations and/or general legislation affecting the operation.
• Coordinates and reviews policy and other regulatory documents drafted by other Centers/Offices that relate to the product review and approval process for biological products.
• Prepares replies to correspondence/inquiries from the regulated industry and other interested person on issues that are industry-wide in scope or have broad health policy implications and that concern precedent setting interpretation of FDA policy.

Requirements
Conditions of Employment
•Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
•Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
•FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility.
•If a discrepancy arises, you must take affirmative steps to resolve the matter. Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action.
• If hired, you may be subject to additional investigations at a later time. Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
• You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered.
• You must continue to meet all requirements through the hiring process. Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification.
• False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.