Regulatory Affairs Specialist

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

Pay: $50$80/hr

Role Title: Regulatory Affairs Specialist

Role Type: Contractor

Location: Remote

This is a fully remote position open to candidates based in United Arab Emirates.

We are engaging Regulatory Affairs Specialists to contribute to a customers project focused on AI innovation in regulatory this role youll apply your expertise to help train next-generation AI systems. Your work will shape how models learn reason and perform through high-quality real-world input. No prior experience in AI is required your domain knowledge is what matters.

Scope of Work

• Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads determining if drafted responses meet regulatory expectations.
• Apply expert judgment to review clinical documentation assessing whether conclusions are substantiated commitments are properly scoped and records can withstand regulatory scrutiny.
• Distinguish between substantively adequate and superficially polished responses articulating clear rationales for any deficiencies.
• Assess consistency across comprehensive document sets identifying unsupported or conflicting claims within or between documents.
• Provide structured well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
• Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.

Preferred 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.
• Demonstrated working knowledge of the ICH framework CTD/eCTD structure and practical expectations of at least one major regulatory body (FDA EMA MHRA PMDA or Health Canada).
• Proven ability to critically read clinical or safety documents to identify regulatory risks unsupported statements and potential reviewer concerns.
• Exceptional written communication skills with the capability to convey regulatory reasoning clearly concisely and defensibly.
• Degree in life sciences pharmacy medicine or a related field; RAC certification is an advantage.
• Experience engaging with multiple regions or agencies prior health authority reviewer/assessor background or familiarity with AI-assisted regulatory tools (all considered valuable).