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Regulatory Counsel

Job in Silver Spring, Montgomery County, Maryland, 20993, USA

Listing for: Department of Health and Human Services

Full Time position
Listed on 2026-07-20

Job specializations:

Government
Emergency Crisis Mgmt/ Disaster Relief
Law/Legal
Emergency Crisis Mgmt/ Disaster Relief

Duties

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Drafts or critically reviews policy documents and program proposals and decisions on these products, including regulations, citizen petition responses, proposed legislation, and policy statements.

Reviews, summarizes, and drafts responses to all public comments received on proposed regulations, recommends adoption or rejection of counter-proposals contained in comments and objections, and drafts final regulations.

Prepares replies to correspondence from the regulated community, Congress, and other interested persons on issues that are industry-wide or have broad health implications and that concern precedent-setting interpretations of laws governing FDA policy

Ensures that regulations and policies developed in the assigned areas are consistent with the statutory requirements and existing policy.

Serves as a regulatory resource in the statutes, regulations, policies, procedures, and implications relevant to the issuance of FDA regulations.

Petitions responses and conducts thorough analyses of complex regulatory and policy issues and provides advice to staff in CDER in carrying out its regulatory mission.

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