Remote Regulatory Affairs Specialist - AI Reg & CTD/eCTD

YO AI Labs; Chicago (IL); Remote; USD 96,000 - 165,000; Part time

Job summary

YO AI Labs is seeking a Regulatory Affairs Specialist for a remote contract role. The candidate should bring 5+ years of regulatory affairs experience in pharma/biotech or CRO, with strong expertise in clinical submissions, ICH guidelines, and CTD/eCTD structure.

In this role you will review regulatory documentation, assess submissions for accuracy and compliance, identify risks, and provide clear, evidence-based feedback to improve AI-generated regulatory content.

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 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 submissions

ICH guidelines

CTD/eCTD

Analytical thinking

Written communication

Education

Bachelor's degree in Life Sciences/Pharmacy/Medicine

Job description

YO AI Labs is seeking a Regulatory Affairs Specialist for a remote contract role. The candidate should bring 5+ years of regulatory affairs experience in pharma/biotech or CRO, with strong expertise in clinical submissions, ICH guidelines, and CTD/eCTD structure.

In this role you will review regulatory documentation, assess submissions for accuracy and compliance, identify risks, and provide clear, evidence-based feedback to improve AI-generated regulatory content.