Remote Regulatory Affairs Specialist (AI & Clinical Docs)

YO AI Labs; Palo Alto (CA); Remote; USD 100,000 - 170,000; Part time

Job summary

YO AI Labs is seeking a Regulatory Affairs Specialist to support AI-driven healthcare projects remotely. You will review and evaluate regulatory documentation, assess submissions for accuracy, and ensure compliance with ICH guidelines and CTD/eCTD structure.

The role requires 5+ years in regulatory affairs, experience with health authority interactions, and strong analytical and written communication skills. This is a contract, remote position suited for experts in pharma/biotech settings.

Qualifications

• 5+ years of regulatory affairs 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 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

Clinical Submissions

ICH Guidelines

CTD/eCTD

Analytical Thinking

Written Communication

Education

Life Sciences, Pharmacy, Medicine, or related field

Job description

YO AI Labs is seeking a Regulatory Affairs Specialist to support AI-driven healthcare projects remotely. You will review and evaluate regulatory documentation, assess submissions for accuracy, and ensure compliance with ICH guidelines and CTD/eCTD structure.

The role requires 5+ years in regulatory affairs, experience with health authority interactions, and strong analytical and written communication skills. This is a contract, remote position suited for experts in pharma/biotech settings.