Regulatory Affairs Expert - Remote

YO AI Labs; Miami (NM); On-site; USD 83,000 - 165,000; Part time

Job summary

YO AI Labs is seeking a Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documentation and ensuring compliance with ICH guidelines. The role involves evaluating clinical documents, identifying inconsistencies, and delivering evidence-based feedback to improve AI-generated regulatory content.

The ideal candidate has 5+ years in Regulatory Affairs, experience with clinical submissions, and a degree in Life Sciences or related field.

Qualifications

• 5+ years of Regulatory Affairs experience in pharma/biotech/CRO.
• Experience with clinical submissions, regulatory docs, and health authority interactions.
• Strong knowledge of ICH guidelines and CTD/eCTD.
• 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 Affairs

Clinical submissions

ICH guidelines

Written communication

Analytical thinking

Education

Life Sciences Degree

Tools

CTD/eCTD knowledge

Job description

Job Title: Regulatory Affairs Specialist

Location: Remote

Job Type: Contract

We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation. The role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content.

Key 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.

Required 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.
• Excellent analytical, critical thinking, and written communication skills.
• Degree in Life Sciences, Pharmacy, Medicine, or a related field.