Regulatory Affairs Specialist (AI Healthcare)

TL;DR

Regulatory Affairs Specialist (AI Healthcare): Reviewing and evaluating regulatory documentation for AI-driven healthcare projects with an accent on compliance with ICH and CTD/eCTD guidelines. Focus on assessing clinical submissions, identifying regulatory risks, and improving AI-generated regulatory content.

Location: Remote

Company

hirify.global provides specialized regulatory and IT consulting services for healthcare and AI-driven projects.

What you will do

• Review and evaluate clinical and regulatory documentation for AI-driven healthcare projects.
• Assess regulatory submissions and responses to ensure accuracy and strict compliance.
• Verify adherence to ICH guidelines and CTD/eCTD requirements.
• Identify regulatory risks, inconsistencies, and unsupported claims within documentation.
• Prepare structured, guideline-based written feedback to improve AI-generated content.

Requirements

• 5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry.
• Proven experience with clinical submissions, regulatory documentation, and health authority interactions.
• Strong professional knowledge of ICH guidelines and CTD/eCTD structure.
• Degree in Life Sciences, Pharmacy, Medicine, or a related field.
• Excellent analytical, critical thinking, and written communication skills.