Remote Regulatory Affairs Specialist (5+ yrs) - AI Health

YO AI Labs; Illinois; Remote; USD 90,000 - 130,000; Full time

Job summary

YO AI Labs seeks a Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documents and ensuring compliance with ICH guidelines. You will assess clinical submissions, identify inconsistencies, and provide evidence-based feedback to improve AI-generated regulatory content.

Collaborating with health authorities and cross-functional teams, you will help align regulatory strategies with project timelines and quality standards in a dynamic AI environment.

Qualifications

• 5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry.
• Experience with clinical submissions, regulatory documentation, 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 a related field.

Responsibilities

• Review and evaluate clinical and regulatory documentation.
• Assess regulatory submissions and responses 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

Analytical thinking

Written communication

Clinical documentation

Health authority interactions

Education

Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field

Tools

CTD/eCTD structure

Job description

YO AI Labs seeks a Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documents and ensuring compliance with ICH guidelines. You will assess clinical submissions, identify inconsistencies, and provide evidence-based feedback to improve AI-generated regulatory content.

Collaborating with health authorities and cross-functional teams, you will help align regulatory strategies with project timelines and quality standards in a dynamic AI environment.