Regulatory Affairs Expert - Remote

YO AI Labs; New York (NY); Remote; USD 83,000 - 124,000; Part time

Job summary

YO AI Labs is seeking a Regulatory Affairs Specialist for remote work to support AI-driven healthcare projects by reviewing regulatory documents and ensuring compliance with guidelines. You will assess clinical submissions, identify regulatory risks, and provide clear, evidence-based feedback to improve CTD/eCTD files, in line with ICH guidelines and health authority expectations.

The candidate should have 5+ years of regulatory affairs experience in pharma, biotech, or CRO sectors, with strong

Qualifications

• Excellent analytical and written communication skills.
• Strong critical thinking and ability to evaluate regulatory documents.
• Experience with regulatory documentation and health authority interactions.

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 and inconsistencies.
• Prepare structured, guideline-based written feedback.

Skills

Analytical thinking

Critical thinking

Written communication

Education

Degree in Life Sciences, Pharmacy, Medicine, or related field

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.