Remote Regulatory Affairs Specialist — AI Submissions

YO AI Labs; Seattle (WA); Remote; USD 90,000 - 150,000; Part time

Job summary

YO AI Labs is seeking a Regulatory Affairs Specialist to support AI-driven healthcare projects. The role focuses on reviewing regulatory documentation, assessing clinical submissions, and ensuring compliance with global guidelines.

You will identify inconsistencies, provide evidence-based feedback to improve AI-generated regulatory content, and coordinate with health authorities as needed on a contract basis.

Qualifications

• 5+ years of Regulatory Affairs experience in pharma/biotech/CRO.
• Experience with clinical submissions and health authority interactions.
• Strong knowledge of ICH guidelines and CTD/eCTD structure.
• Excellent analytical, critical thinking, and written communication skills.
• Degree in Life Sciences, Pharmacy, Medicine, or related field.

Responsibilities

• Review and evaluate clinical and regulatory documentation.
• Assess regulatory submissions for accuracy and compliance.
• Ensure adherence to ICH guidelines and CTD/eCTD requirements.
• Identify regulatory risks and unsupported claims.
• Prepare structured, guideline-based written feedback.

Skills

5+ years Regulatory Affairs experience

Analytical thinking

Written communication

Education

Degree in Life Sciences/Pharmacy/Medicine

Job description

YO AI Labs is seeking a Regulatory Affairs Specialist to support AI-driven healthcare projects. The role focuses on reviewing regulatory documentation, assessing clinical submissions, and ensuring compliance with global guidelines.

You will identify inconsistencies, provide evidence-based feedback to improve AI-generated regulatory content, and coordinate with health authorities as needed on a contract basis.