Remote FDA Regulatory Counsel for Life Sciences

micro1; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

micro1 is seeking an FDA & Regulatory Compliance Attorney for a remote contractor role. You will analyze FDA statutes, review regulatory submissions, assess regulatory risk, and draft clear explanations for diverse audiences.

Applicants should hold a JD with an active US license and 5+ years in FDA law or regulatory compliance within life sciences. Strong communication and attention to detail are essential.

Qualifications

• JD degree and active license to practice law in the United States.
• 5+ years of FDA law, regulatory strategy, or compliance experience in life sciences.
• Strong understanding of federal regulatory processes, submission pathways, and compliance protocols.
• Outstanding written and verbal communication skills, with ability to convey complex legal concepts clearly.
• Experience advising or representing clients in FDA investigations, warning letters, or consent decrees is advantageous.
• Detail-oriented with ability to distill actionable insights from regulatory developments.

Responsibilities

• Analyze and interpret FDA statutes, regulations, and guidance documents to provide domain-specific insights.
• Review and critique regulatory submissions, compliance documentation, and procedural materials.
• Assess real-world scenarios for regulatory risk, enforcement trends, and liability considerations.
• Draft or edit scenario-based questions and answers elucidating regulatory best practices.
• Identify emerging issues in FDA and broader regulatory compliance and recommend practical solutions.
• Generate clear, concise written and verbal explanations of complex legal requirements for technical and non-technical audiences.
• Contribute to the continuous improvement of project deliverables through feedback on content accuracy and completeness.

Skills

fda regulatory analysis

legal research

regulatory compliance

risk assessment

regulatory submissions

legal writing

verbal communication

life sciences industry knowledge

attention to detail

issue spotting and resolution

Education

Juris Doctor (JD)

Job description

micro1 is seeking an FDA & Regulatory Compliance Attorney for a remote contractor role. You will analyze FDA statutes, review regulatory submissions, assess regulatory risk, and draft clear explanations for diverse audiences.

Applicants should hold a JD with an active US license and 5+ years in FDA law or regulatory compliance within life sciences. Strong communication and attention to detail are essential.