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.