Senior Scientific Regulatory Documentation Specialist

Job Title: Senior Scientific Regulatory Documentation Specialist
Location: United Arab Emirates (Remote)
Employment Type: Full-Time
Work Arrangement: 100% Remote — Work From Home
Level: Senior
About the Role
We are seeking an experienced Senior Scientific Regulatory Documentation Specialist to manage and coordinate scientific and technical documentation supporting regulatory compliance, product registrations, and regulatory submissions. This role focuses on reviewing scientific evidence, preparing technical documentation, maintaining regulatory records, monitoring submission requirements, and coordinating documentation activities across research, quality, manufacturing, clinical, and regulatory teams.
The successful candidate will have strong knowledge of scientific documentation practices, regulatory frameworks, technical writing, and controlled document management. Working fully remotely, the specialist will ensure that scientific and regulatory information is accurate, consistent, traceable, and organized in accordance with applicable quality standards and regulatory expectations.
Key Responsibilities
* Prepare, review, and coordinate scientific and technical documentation for regulatory submissions, product registrations, and compliance assessments.
* Compile and review technical reports, scientific summaries, study documentation, product specifications, validation records, and supporting evidence.
* Coordinate the preparation of regulatory dossiers and submission packages in accordance with applicable regional and international requirements.
* Review scientific data and technical documents for completeness, consistency, accuracy, and alignment with established documentation standards.
* Support documentation relating to product development, manufacturing processes, quality controls, analytical testing, and product safety.
* Maintain controlled regulatory documentation, including document versions, approval histories, submission records, and audit trails.
* Coordinate with scientific, laboratory, clinical, quality assurance, manufacturing, and regulatory affairs teams to obtain supporting information.
* Track regulatory submission timelines, documentation gaps, review comments, and outstanding actions.
* Review regulatory correspondence and support the preparation of responses to questions and requests for additional information.
* Monitor changes in applicable scientific, technical, and regulatory requirements and assess their potential impact on documentation.
* Support the maintenance of product technical files, scientific reference materials, regulatory databases, and submission archives.
* Conduct documentation gap assessments and recommend corrective actions to improve submission quality and compliance readiness.
* Prepare technical summaries, regulatory status reports, document trackers, and management updates.
* Support internal and external audits by organizing documentation, verifying records, and coordinating responses to audit findings.
* Recommend improvements to scientific writing standards, document workflows, review processes, and regulatory information management systems.
Qualifications and Experience
* Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Biomedical Science, Regulatory Affairs, or a related scientific discipline.
* Significant experience in scientific documentation, regulatory affairs, technical writing, quality documentation, or regulated product submissions.
* Strong understanding of scientific and technical documentation requirements in pharmaceutical, biotechnology, medical device, healthcare, or related regulated industries.
* Experience preparing and reviewing technical reports, scientific summaries, product specifications, validation documentation, and regulatory submission materials.
* Familiarity with relevant regulatory frameworks, quality management systems, and applicable Good Practice requirements.
* Knowledge of regulatory submission processes and electronic document management systems.
* Experience with document control, version management, traceability, and formal review and approval workflows.
* Strong scientific writing, editing, analytical, and information management skills.
* Ability to interpret technical and scientific information and communicate it clearly to regulatory and non-regulatory stakeholders.
* Excellent organizational skills and the ability to manage multiple documentation projects and deadlines.
* High standards of accuracy, confidentiality, integrity, and attention to detail.
* Ability to work independently and collaborate effectively with international teams in a fully remote environment.
What We Offer
* A fully remote, work-from-home position.
* Competitive compensation based on qualifications and relevant experience.
* Opportunities to support scientific and regulatory documentation across regulated industries.
* Exposure to international regulatory frameworks, technical dossiers, and quality management practices.
* Professional development and opportunities to strengthen scientific writing and regulatory expertise.
* A collaborative environment focused on documentation quality, compliance, and continuous improvement.
How to Apply
Interested candidates should submit an updated CV highlighting their experience in scientific documentation, regulatory submissions, technical writing, quality systems, and document management.
Application Subject: Application – Senior Scientific Regulatory Documentation Specialist (UAE Remote)
Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer.
* Important Scope of Responsibilities: This is a fully remote scientific documentation, technical review, regulatory coordination, and compliance support role. Physical laboratory testing, specimen collection and handling, manufacturing activities, product inspections, equipment operation, clinical investigations, and on-site facility assessments must be performed by qualified local personnel. Scientific or clinical judgments requiring professional authorization, formal regulatory submissions, product registrations, declarations, certifications, clinical or safety determinations, quality release approvals, legal representations, and statutory regulatory sign-offs must be completed or approved by appropriately qualified and authorized scientific, medical, regulatory, quality, legal, or compliance professionals.