Regulatory Affairs Specialist (AI)

Location: Remote

Company

hirify.global is running an innovative project focused on improving AI-driven regulatory documentation systems.

What you will do

• Author and review evaluation tasks based on regulatory requests, submissions, and sponsor response scenarios.
• Review clinical documentation for regulatory compliance, accuracy, and alignment with health authority expectations.
• Evaluate regulatory responses for completeness, justification, and submission readiness.
• Identify unsupported claims, inconsistencies, and 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

• Regulatory affairs experience, including clinical documentation review and regulatory submissions.
• Knowledge of ICH guidelines and CTD/eCTD structure.
• Experience with health authority interactions and regulatory standards.
• Strong written communication, critical thinking, and attention to detail.
• 5+ years of direct regulatory affairs experience within a sponsor, CRO, or consultancy environment.
• Degree in life sciences, pharmacy, medicine, or a related field.

Nice to have

• Experience managing clinical submissions and responding to health authority information requests.
• Knowledge of FDA, EMA, MHRA, PMDA, or Health Canada expectations.
• Prior health authority reviewer experience or experience working across multiple regions.
• Familiarity with AI-assisted regulatory tools.
• RAC certification.

Culture & Benefits

• Remote collaboration with project teams.
• No prior AI experience is required.
• Contractor engagement.