Remote Regulatory Affairs Specialist for AI Projects

RemoteJobsOne; Dubai; Remote; AED 253,000 - 405,000; Full time

Job summary

RemoteJobsOne is seeking a Regulatory Affairs Specialist for a fully remote contract role open to candidates based in the United Arab Emirates. You will apply regulatory expertise to support AI-focused regulatory workflows and provide high-quality written input to training data for next-generation systems.

Applicants should have strong experience in regulatory submissions, ICH CTD/eCTD guidance, and familiarity with major regulators.

Qualifications

• 5 years of direct regulatory affairs experience at a sponsor CRO or consultancy with responsibility for clinical submissions.
• Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
• Working knowledge of ICH framework, CTD/eCTD structure and expectations of major regulators (FDA/EMA/MHRA/PMDA/Health Canada).
• Proven ability to critically read clinical or safety documents to identify regulatory risks and reviewer concerns.
• Exceptional written communication skills with clear, concise regulatory reasoning.

Responsibilities

• Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads.
• Assess clinical documentation to determine whether conclusions are substantiated and records can withstand regulatory scrutiny.
• Distinguish between substantively adequate and superficially polished responses with clear rationales for deficiencies.
• Assess consistency across large document sets and identify unsupported or conflicting claims.
• Provide structured, well-reasoned written feedback grounded in regulatory guidelines.
• Collaborate asynchronously and communicate complex regulatory concepts clearly in written and verbal form.

Skills

Regulatory affairs

ICH framework

Regulatory writing

Clinical submissions

Written communication

Education

Bachelor's degree in life sciences

RAC certification

Job description

RemoteJobsOne is seeking a Regulatory Affairs Specialist for a fully remote contract role open to candidates based in the United Arab Emirates. You will apply regulatory expertise to support AI-focused regulatory workflows and provide high-quality written input to training data for next-generation systems.

Applicants should have strong experience in regulatory submissions, ICH CTD/eCTD guidance, and familiarity with major regulators.