Remote Regulatory Affairs Specialist for AI-Driven HealthTech

YO AI Labs; Los Angeles (CA); Remote; USD 90,000 - 130,000; Full time

Job summary

YO AI Labs is seeking a Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documentation and ensuring regulatory compliance. The role focuses on clinical documents, identifying inconsistencies, and providing clear feedback to improve AI-generated regulatory content.

The ideal candidate has 5+ years in Regulatory Affairs, experience with clinical submissions, and 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

RA experience

Clinical submissions

ICH guidelines

CTD/eCTD knowledge

Analytical skills

Written communication

Education

Life Sciences or related field degree

Job description

YO AI Labs is seeking a Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documentation and ensuring regulatory compliance. The role focuses on clinical documents, identifying inconsistencies, and providing clear feedback to improve AI-generated regulatory content.

The ideal candidate has 5+ years in Regulatory Affairs, experience with clinical submissions, and strong knowledge of ICH guidelines and CTD/eCTD structure.