Remote Regulatory Affairs Specialist AI Healthcare Contract

YO AI Labs; Austin (TX); Remote; USD 90,000 - 130,000; Part time

Job summary

YO AI Labs is seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documentation and evaluating clinical submissions. You will ensure compliance with ICH guidelines and CTD/eCTD requirements, identify risks, and provide structured, evidence-based feedback to improve regulatory content.

The role requires 5+ years in Regulatory Affairs, experience with clinical submissions and health authority interactions, and a related degree in

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.

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

Education

Life Sciences, Pharmacy, Medicine, or related field

Job description

YO AI Labs is seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documentation and evaluating clinical submissions. You will ensure compliance with ICH guidelines and CTD/eCTD requirements, identify risks, and provide structured, evidence-based feedback to improve regulatory content.

The role requires 5+ years in Regulatory Affairs, experience with clinical submissions and health authority interactions, and a related degree in