Regulatory Affairs Expert - Remote

YO AI Labs; Houston (TX); Remote; USD 83,000 - 138,000; Part time

Job summary

YO AI Labs is seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing regulatory documentation, assessing clinical materials, and ensuring compliance with ICH CTD/eCTD guidelines.

You will identify inconsistencies, provide evidence-based feedback, and prepare structured submissions for health authority interactions. This is a remote contract role with flexible hours.

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 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 knowledge

Analytical thinking

Written communication

Clinical document review

Education

Degree in Life Sciences/Pharmacy/Medicine

Job description

Job Title: Regulatory Affairs Specialist

Location: Remote

Job Type: Contract

Job Description

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.