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
The Senior Scientific Regulatory Documentation Specialist is responsible for preparing, reviewing, coordinating, and maintaining scientific and technical documentation required to support regulatory submissions, product registrations, compliance assessments, and ongoing regulatory activities. The role focuses on scientific data interpretation, document quality, technical consistency, regulatory requirements tracking, and submission readiness across relevant product and industry categories, including pharmaceuticals, biotechnology, medical devices, chemicals, and healthcare-related products. Working fully remotely, the specialist collaborates with scientific, quality assurance, regulatory affairs, manufacturing, research, and legal teams to ensure that documentation is accurate, traceable, and aligned with applicable regulatory standards.

Key Responsibilities
Prepare, review, and coordinate scientific and technical documents supporting regulatory submissions and product compliance activities. Compile technical information from research reports, laboratory records, clinical documentation, manufacturing data, and quality management systems. Review scientific reports, product specifications, analytical results, validation records, stability data, and technical summaries for accuracy and consistency. Develop and maintain regulatory document packages, including technical dossiers, product information files, scientific justifications, and supporting evidence. Coordinate the preparation of regulatory submission sections and supporting documentation in accordance with applicable frameworks. Review scientific terminology, data references, tables, figures, appendices, and document formatting to ensure completeness and consistency. Assess documentation against relevant regulatory guidance, technical standards, and internal quality requirements. Track regulatory changes and assess their potential impact on existing documentation, product records, and submission requirements. Coordinate responses to regulatory questions and requests for additional scientific or technical information. Maintain document version control, approval records, change histories, and traceability across regulatory documentation systems. Identify missing evidence, conflicting data, outdated references, and documentation gaps, and coordinate corrective actions with subject-matter experts. Support the preparation of risk assessments, scientific rationales, benefit-risk summaries, and technical explanations. Collaborate with quality assurance teams to ensure alignment between regulatory submissions, controlled procedures, and quality records. Coordinate document review cycles with internal specialists, external consultants, and relevant technical stakeholders. Maintain regulatory calendars, submission trackers, document inventories, and outstanding-action logs. Support audit and inspection readiness by organizing scientific records and retrieving relevant documentation. Prepare management reports on submission progress, document quality, regulatory changes, and outstanding compliance activities. Recommend improvements to document templates, review workflows, metadata standards, and regulatory information management processes. Qualifications and Experience Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Biomedical Science, Regulatory Affairs, or a related scientific discipline. A postgraduate qualification or professional certification in Regulatory Affairs or Scientific Documentation is an advantage. Significant experience in scientific documentation, regulatory affairs, technical writing, or regulated product compliance. Strong understanding of scientific data interpretation and technical documentation requirements. Experience preparing or reviewing regulatory dossiers, technical reports, product documentation, and supporting evidence. Familiarity with relevant regulatory frameworks and guidance applicable to pharmaceuticals, medical devices, biotechnology, chemicals, or other regulated products. Knowledge of document control, change management, data integrity, and quality management principles. Ability to interpret laboratory reports, validation documents, stability data, product specifications, and scientific study findings. Experience with electronic document management systems, regulatory information management platforms, and Microsoft Office applications. Strong technical writing, editing, proofreading, and information organization skills. Excellent attention to detail and ability to identify inconsistencies in complex scientific records. Ability to manage multiple documentation projects and meet submission deadlines. Strong communication and stakeholder coordination skills. Ability to work indep