Senior Scientific Regulatory Documentation Specialist

HL Mando Corporation do Brasil; Abu Dhabi; Remote; AED 167.000 - 279.000; Vollzeit

Zusammenfassung

HL Mando Corporation do Brasil in UAE seeks a Senior Scientific Regulatory Documentation Specialist to prepare and review scientific documents for regulatory submissions across pharma, biotech, medical devices, and chemicals. The role is fully remote in the United Arab Emirates, requiring coordination with QA, regulatory affairs, manufacturing, and legal teams to ensure traceability and compliance.

Responsibilities include maintaining document control, addressing data gaps, and tracking

Qualifikationen

• Bachelor degree in a scientific discipline related to regulatory work.
• Postgraduate qualification in Regulatory Affairs or Scientific Documentation is an advantage.
• Experience in scientific documentation, regulatory affairs, technical writing, or regulated product compliance.
• Knowledge of document control, change management, data integrity and quality management principles.

Aufgaben

• Prepare, review, and coordinate scientific and technical documents for regulatory submissions and product compliance.
• Compile information from research reports, lab records, and manufacturing data.
• Review reports, specifications, validation records, and data for accuracy and consistency.
• Develop and maintain regulatory document packages and submission sections.
• Track regulatory changes and assess impact on documentation and submissions.
• Maintain document version control, approval records, and traceability.
• Coordinate responses to regulatory questions and requests for information.
• Ensure alignment between regulatory submissions and quality records.
• Manage submission calendars, trackers, and inventories.

Kenntnisse

Scientific writing

Regulatory writing

Documentation management

Stakeholder coordination

Microsoft Office

Regulatory information management

Data interpretation

Quality management principles

Technical editing

Attention to detail

Ausbildung

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Biomedical Science, Regulatory Affairs, or related

Postgraduate qualification or professional certification in Regulatory Affairs or Scientific Documentation

Tools

Microsoft Office

Electronic Document Management Systems (EDMS)

Jobbeschreibung

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 independently and collaborate effectively with multidisciplinary teams in a fully remote environment.

What We Offer

• Fully remote working arrangement within the stated UAE-based role framework.
• Opportunity to support scientific and regulatory documentation across complex product portfolios.
• Collaboration with multidisciplinary scientific, quality, and regulatory professionals.
• A structured environment emphasizing documentation accuracy, traceability, and regulatory compliance.
• Opportunities for professional development in regulatory affairs and scientific technical writing.

• Candidates should confirm applicable employment arrangements, residency requirements, and work authorization before accepting an offer. Formal regulatory submissions, declarations, certifications, statutory sign-offs, and communications requiring licensed or delegated regulatory authority must be reviewed, approved, and submitted by appropriately authorized personnel in accordance with applicable laws and regulatory requirements.