FDA Regulatory Counsel - Shape Health Policy

U.S. Food and Drug Administration (FDA); Silver Spring (MD); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Telework eligible

Job summary

U.S. Food and Drug Administration (FDA) is seeking a Regulatory Counsel to draft and review policy documents and proposed regulations governing FDA-regulated products. You will respond to public comments, draft final rules, and advise on interpretations of laws and guidance relevant to FDA policy.

Qualified candidates have a law degree (J.D. or LL.M.) and multiple years of experience interpreting statutes, regulations, and policy; experience with CDER and regulatory processes is preferred.

Qualifications

• Law degree (J.D. or LL.M.) from an accredited program.
• Experience analyzing and advising on interpretation of laws and regulations applicable to FDA-regulated products.
• Ability to develop, implement, and evaluate regulations and policies to ensure safety, efficacy, and quality.

Responsibilities

• Draft or critically review policy documents and proposals related to FDA-regulated products.
• Review and draft responses to public comments on proposed regulations and prepare final regulations.
• Prepare replies to correspondence concerning precedent-setting interpretations of FDA laws and policies.
• Ensure regulatory work aligns with statutory requirements and existing policy.
• Serve as a regulatory resource on statutes, regulations, policies, and implications for FDA regulations.
• Provide analyses and advice on complex regulatory issues to staff in CDER.

Skills

Legal analysis

Regulatory policy

FDA regulations

Public policy review

Education

J.D. or LL.M.

Job description

U.S. Food and Drug Administration (FDA) is seeking a Regulatory Counsel to draft and review policy documents and proposed regulations governing FDA-regulated products. You will respond to public comments, draft final rules, and advise on interpretations of laws and guidance relevant to FDA policy.

Qualified candidates have a law degree (J.D. or LL.M.) and multiple years of experience interpreting statutes, regulations, and policy; experience with CDER and regulatory processes is preferred.