Regulatory Affairs Specialist (AI)

TL;DR

Regulatory Affairs Specialist (AI): Refining AI-driven regulatory documentation systems by reviewing and evaluating regulatory content and clinical documentation with an accent on compliance and health authority expectations. Focus on identifying regulatory risks, authoring evaluation tasks, and ensuring alignment with ICH guidelines and CTD structures.

Location: Remote

Company

hirify.global provides expert consulting services for innovative AI-driven projects.

What you will do

• Author and review evaluation tasks based on real-world regulatory requests, submissions, and sponsor response scenarios.
• Review clinical documentation to assess regulatory compliance and alignment with health authority expectations.
• Evaluate regulatory responses to determine completeness, justification, and readiness for submission.
• Identify unsupported claims, inconsistencies, and potential regulatory risks across document sets.
• Provide structured, guideline-based written feedback and recommendations.
• Collaborate remotely with project teams to communicate complex regulatory concepts clearly.

Requirements

• Deep expertise in Regulatory Affairs, ICH Guidelines, and CTD/eCTD structures.
• Experience with regulatory submissions and interactions with health authorities (e.g., FDA, EMA, MHRA, PMDA, or Health Canada).
• Ability to critically review clinical and safety documents to identify regulatory risks.
• Excellent written communication skills for presenting regulatory reasoning clearly and accurately.
• Degree in life sciences, pharmacy, medicine, or a related field.
• 5+ years of direct regulatory affairs experience within a sponsor, CRO, or consultancy environment.

Nice to have

• RAC certification.
• Prior experience as a health authority reviewer.
• Familiarity with AI-assisted regulatory tools.
• Experience working across multiple geographic regions.