[Hiring] Regulatory Affairs Specialist @YO AI Labs

Role Description

We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation. The role involves:

• Reviewing and evaluating clinical and regulatory documentation.
• Assessing regulatory submissions and responses for accuracy and compliance.
• Ensuring adherence to ICH guidelines and CTD/eCTD requirements.
• Identifying regulatory risks, inconsistencies, and unsupported claims.
• Preparing structured, guideline-based written feedback.

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.

Company Description