AI-Driven Regulatory Affairs Specialist (Remote, Contract)

YO AI Labs; Illinois; On-site; USD 124,000 - 165,000; Full time

Job summary

YO AI Labs seeks a Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documentation and ensuring regulatory compliance.

You will assess clinical documents, identify inconsistencies, and provide evidence-based feedback to improve AI-generated regulatory content. This contract role requires 5+ years of RA experience with strong knowledge of ICH guidelines and CTD/eCTD structure.

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 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, inconsistencies, and unsupported claims.
• Prepare structured, guideline-based written feedback.

Skills

Regulatory affairs

Clinical submissions

ICH guidelines

Written communication

Analytical thinking

Education

Bachelor's degree in Life Sciences or related field

Job description

YO AI Labs seeks a Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documentation and ensuring regulatory compliance.

You will assess clinical documents, identify inconsistencies, and provide evidence-based feedback to improve AI-generated regulatory content. This contract role requires 5+ years of RA experience with strong knowledge of ICH guidelines and CTD/eCTD structure.