Remote FDA Regulatory Counsel

Crossing Hurdles; United States; Remote; USD 193,000 - 551,000; Part time

Job summary

Crossing Hurdles is seeking an experienced FDA & Regulatory Compliance Attorney for a remote contract position. The role involves analyzing FDA statutes, regulations, and guidance, reviewing regulatory submissions, and assessing regulatory risk to guide client decisions.

The ideal candidate holds a JD with an active USA license, excellent legal research and writing skills, and the ability to convey complex regulatory concepts to diverse audiences.

Qualifications

• Experience with FDA regulatory analysis and compliance documentation.
• Strong legal research skills with attention to detail.
• Verbal communication skills for conveying complex concepts.

Responsibilities

• Analyze and interpret FDA statutes, regulations, and guidance documents.
• Review and critique regulatory submissions and compliance documentation.
• Assess scenarios for regulatory risk and enforcement trends.
• Draft or edit scenario-based questions and answers for regulatory practices.
• Identify emerging issues in FDA compliance and recommend solutions.
• Generate clear explanations of complex legal requirements for audiences.
• Contribute feedback on project deliverables for content accuracy.

Skills

FDA regulations

Legal research

Legal writing

Regulatory risk assessment

Verbal communication

Education

Juris Doctor (JD)

Job description

Crossing Hurdles is seeking an experienced FDA & Regulatory Compliance Attorney for a remote contract position. The role involves analyzing FDA statutes, regulations, and guidance, reviewing regulatory submissions, and assessing regulatory risk to guide client decisions.

The ideal candidate holds a JD with an active USA license, excellent legal research and writing skills, and the ability to convey complex regulatory concepts to diverse audiences.