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 the preparation, review, coordination, and maintenance of scientific and technical documentation required for regulatory submissions and compliance activities. The role supports the registration and lifecycle management of pharmaceutical products, medical devices, biotechnology products, chemicals, or other regulated scientific products, depending on business requirements. The successful candidate will combine strong scientific literacy with regulatory writing expertise, document control discipline, and a detailed understanding of applicable regulatory standards.

Key Responsibilities

• Prepare, review, and coordinate scientific and technical documentation for regulatory submissions and product registration activities.
• Compile and maintain regulatory dossiers, technical files, supporting evidence, and submission records.
• Draft and edit scientific summaries, technical reports, product information documents, and regulatory responses.
• Review nonclinical, clinical, analytical, manufacturing, quality, and stability documentation for accuracy and consistency.
• Coordinate the collection of technical information from research, development, quality assurance, manufacturing, clinical, and regulatory teams.
• Ensure documentation aligns with applicable regulatory guidelines, submission formats, and authority requirements.
• Support preparation and maintenance of Common Technical Document (CTD) and electronic Common Technical Document (eCTD) modules where relevant.
• Review scientific terminology, data presentation, references, tables, figures, and supporting appendices.
• Identify gaps, inconsistencies, outdated information, and missing evidence within regulatory documentation.
• Coordinate responses to regulatory authority questions, requests for clarification, and deficiency notices.
• Maintain document version control, change histories, approval records, and controlled templates.
• Track regulatory submission timelines, documentation dependencies, review cycles, and outstanding actions.
• Support product variations, renewals, amendments, post-approval changes, and lifecycle documentation.
• Review scientific claims and product statements to ensure they are supported by appropriate evidence.
• Coordinate translation, formatting, publishing, and technical validation activities for regulatory documents.
• Maintain regulatory intelligence records and monitor changes in relevant scientific and regulatory guidance.
• Support internal and external audits by organizing controlled documentation and traceable evidence.
• Collaborate with subject matter experts to resolve technical queries and improve document quality.
• Develop standardized writing procedures, document checklists, and quality review processes.
• Prepare progress reports on submission readiness, document completion, review findings, and regulatory milestones.
• Provide technical guidance and mentoring to junior regulatory documentation specialists.

Qualifications and Experience

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Biomedical Sciences, or a related scientific discipline.
• Advanced degree in a relevant scientific or regulatory field is advantageous.
• Significant experience in scientific writing, regulatory affairs documentation, technical documentation, or regulatory submissions.
• Strong understanding of regulatory documentation requirements for pharmaceutical, biotechnology, medical device, or other regulated products.
• Experience preparing or reviewing scientific reports, technical summaries, and regulatory submission materials.
• Familiarity with CTD/eCTD structures and regulatory submission workflows where applicable.
• Knowledge of relevant guidelines, including ICH guidance and applicable quality, safety, and efficacy documentation standards.
• Understanding of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) documentation principles where relevant.
• Ability to interpret scientific data and communicate complex technical information accurately.
• Experience reviewing analytical, stability, nonclinical, clinical, or manufacturing documentation.
• Strong technical editing, proofreading, referencing, and document quality assurance skills.
• Familiarity with regulatory document management systems and electronic submission publishing tools.
• Understanding of document lifecycle management, version control, and controlled approval processes.
• Excellent written English and scientific communication skills.
• Strong organizational skills and the ability to manage multiple documentation projects and deadlines.
• High attention to detail, accuracy, confidentiality, and data integrity.
• Ability to collaborate effectively with multidisciplinary teams in a remote working environment.
• Relevant regulatory affairs or scientific writing certifications are advantageous.

What We Offer

• A fully remote working arrangement within the UAE employment context.
• Competitive compensation aligned with qualifications and experience.
• Opportunities to contribute to complex scientific and regulatory submission projects.
• Professional development in regulatory affairs, scientific writing, and document quality management.
• A collaborative environment involving scientific, quality, and regulatory professionals.

How to Apply

Interested candidates should submit an updated CV highlighting their scientific background, regulatory documentation experience, technical writing capabilities, and familiarity with relevant submission standards.

Email 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 focuses on remote scientific writing, document review, submission coordination, regulatory intelligence, and documentation quality assurance. Laboratory testing, clinical activities, manufacturing verification, and other physical technical work must be conducted by appropriately qualified local personnel. Formal regulatory certifications, authority submissions, product approvals, and legally binding regulatory representations must be completed or authorized by appropriately qualified and authorized personnel in accordance with applicable requirements.