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, review, and coordinate scientific and technical documentation required for regulatory submissions, product registrations, compliance assessments, and ongoing regulatory maintenance. The successful candidate will ensure scientific information is accurate, consistent, traceable, and aligned with applicable regulatory guidelines. This fully remote role focuses on technical writing, scientific data review, regulatory document preparation, submission coordination, and collaboration with research, quality assurance, clinical, manufacturing, and regulatory affairs teams.

Key Responsibilities

• Prepare, review, and maintain scientific and technical documentation for regulatory submissions and product approval processes.
• Develop regulatory documents, technical reports, scientific summaries, product dossiers, and supporting evidence packages.
• Review scientific data, research findings, laboratory reports, and technical records for accuracy and completeness.
• Coordinate the preparation of regulatory submission documents in accordance with applicable regional and international requirements.
• Compile and review product quality, safety, efficacy, and performance documentation.
• Ensure scientific statements, technical claims, and supporting evidence are consistent across regulatory documents.
• Review study reports, validation records, analytical data, stability reports, and relevant scientific publications.
• Support the preparation and maintenance of Common Technical Document (CTD) and electronic Common Technical Document (eCTD) sections where applicable.
• Coordinate document requests and technical clarifications with regulatory authorities through authorized regulatory affairs personnel.
• Monitor changes in regulatory guidelines, scientific standards, and documentation requirements.
• Maintain document control systems, version histories, approval records, and submission tracking registers.
• Review technical documentation for consistency with approved product specifications, manufacturing information, and quality standards.
• Collaborate with scientists, researchers, quality specialists, clinical teams, and regulatory professionals to obtain and verify technical information.
• Identify documentation gaps, inconsistencies, and potential compliance risks and coordinate corrective actions.
• Support regulatory responses by organizing scientific evidence and preparing draft technical explanations.
• Prepare literature reviews, scientific summaries, risk assessments, and evidence-based technical reports.
• Assist with internal audits, regulatory inspections, and documentation readiness assessments.
• Establish and improve standard operating procedures, document templates, review checklists, and regulatory documentation workflows.
• Provide technical guidance and mentoring to junior scientific writers and documentation specialists.
• Ensure confidential scientific, clinical, product, and proprietary information is handled securely.

Qualifications and Experience

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Biomedical Sciences, Pharmaceutical Sciences, or a related scientific discipline.
• A master's degree or postgraduate qualification in Regulatory Affairs, Pharmaceutical Sciences, or Scientific Research is an advantage.
• Significant professional experience in scientific documentation, regulatory affairs, technical writing, pharmaceutical documentation, or scientific quality management.
• Strong understanding of regulatory documentation requirements and scientific evidence assessment.
• Experience preparing and reviewing technical reports, scientific summaries, product dossiers, and regulatory submission materials.
• Familiarity with CTD/eCTD structures and regulatory submission processes where applicable.
• Knowledge of pharmaceutical, biotechnology, medical device, or healthcare product regulatory frameworks.
• Experience reviewing laboratory reports, analytical results, stability data, validation documentation, and scientific study reports.
• Understanding of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) principles where relevant.
• Ability to interpret scientific literature, technical data, and regulatory guidance documents.
• Familiarity with document management systems, electronic submission platforms, and regulatory information management tools.
• Proficiency in Microsoft Word, Excel, PowerPoint, and scientific documentation applications.
• Strong scientific writing, editing, proofreading, and technical communication skills.
• Excellent analytical skills and attention to detail.
• Ability to manage multiple documentation projects, review cycles, and regulatory deadlines independently.
• Strong communication and collaboration skills for working with multidisciplinary and geographically distributed teams.
• Relevant certifications in Regulatory Affairs, Scientific Writing, Quality Management, or Pharmaceutical Compliance are an advantage.

What We Offer

• A fully remote, work-from-home position within the UAE employment context.
• Competitive compensation based on qualifications and relevant professional experience.
• Opportunities to contribute to scientific regulatory submissions and international compliance projects.
• Professional development in regulatory affairs, scientific writing, technical documentation, and quality systems.
• A collaborative working environment focused on scientific accuracy, documentation excellence, and continuous improvement.

How to Apply

Interested candidates should submit an updated CV highlighting their experience in scientific writing, regulatory documentation, technical report preparation, product dossiers, and regulatory submission support.

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. This role is designed for remote scientific documentation, technical review, regulatory research, submission preparation, and virtual coordination. Laboratory testing, physical sample handling, and on-site scientific investigations must be conducted by qualified local personnel. Formal regulatory certifications, official submissions, product approvals, and representations before regulatory authorities must be completed or endorsed by appropriately qualified and authorized professionals in accordance with applicable laws and regulatory requirements.