Remote Regulatory Affairs Specialist - AI Submissions

YO AI Labs; New York (NY); Remote; USD 83,000 - 124,000; Part time

Job summary

YO AI Labs is seeking a Regulatory Affairs Specialist for remote work to support AI-driven healthcare projects by reviewing regulatory documents and ensuring compliance with guidelines. You will assess clinical submissions, identify regulatory risks, and provide clear, evidence-based feedback to improve CTD/eCTD files, in line with ICH guidelines and health authority expectations.

The candidate should have 5+ years of regulatory affairs experience in pharma, biotech, or CRO sectors, with strong

Qualifications

• Excellent analytical and written communication skills.
• Strong critical thinking and ability to evaluate regulatory documents.
• Experience with regulatory documentation and health authority interactions.

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 inconsistencies.
• Prepare structured, guideline-based written feedback.

Skills

Analytical thinking

Critical thinking

Written communication

Education

Degree in Life Sciences, Pharmacy, Medicine, or related field

Job description

YO AI Labs is seeking a Regulatory Affairs Specialist for remote work to support AI-driven healthcare projects by reviewing regulatory documents and ensuring compliance with guidelines. You will assess clinical submissions, identify regulatory risks, and provide clear, evidence-based feedback to improve CTD/eCTD files, in line with ICH guidelines and health authority expectations.

The candidate should have 5+ years of regulatory affairs experience in pharma, biotech, or CRO sectors, with strong