Senior Regulatory Affairs Specialist

🏗 We're Hiring: Senior Regulatory Affairs Specialist
Location: United Arab Emirates (Remote)
Employment Type: Full-Time
Experience Level: Mid-Level to Senior
Work Arrangement: Fully Remote
About Us
We are a construction-focused organization committed to delivering complex projects through disciplined contract management, commercial excellence, risk control, and collaborative project delivery. Our distributed teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Legal, Finance, Human Resources, Design, Quality, HSE, Consultants, Contractors, Suppliers, Logistics, Administration, Information Technology, and Executive Leadership to maintain high standards of regulatory compliance, operational integrity, quality assurance, and professional accountability across diverse industries and business functions.
We value precision, transparency, continuous improvement, and responsible business practices. Through structured governance, effective documentation, and proactive regulatory management, we aim to ensure that our operations, products, services, and partnerships meet applicable legal requirements and recognized industry standards.
The Role
We are seeking an experienced Senior Regulatory Affairs Specialist to manage and coordinate regulatory activities, support product and operational compliance, and ensure that relevant business processes align with applicable regulatory requirements. The ideal candidate will bring strong expertise in regulatory research, submission management, compliance documentation, regulatory intelligence, quality systems, and cross-functional coordination within regulated industries, particularly pharmaceutical, medical device, healthcare, and life sciences environments where applicable.
This role will focus on interpreting regulatory requirements, preparing and maintaining submission documentation, monitoring regulatory changes, coordinating approval processes, and minimizing compliance risks throughout the product and operational lifecycle. The Senior Regulatory Affairs Specialist will collaborate with Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Legal, Procurement, Engineering, Project Management, external consultants, suppliers, and senior leadership to ensure compliance with relevant United Arab Emirates laws and regulations, applicable international standards, contractual obligations, and organizational procedures.
Key Responsibilities
Develop, implement, and maintain regulatory affairs policies, procedures, workflows, and documentation standards.
Monitor applicable UAE laws, regulations, regulatory guidance, and industry standards affecting assigned products, services, and business operations.
Conduct regulatory research and interpret requirements relevant to product registration, licensing, certification, manufacturing, distribution, and post-market obligations.
Monitor regulatory developments and assess their potential impact on business activities, product portfolios, and operational processes.
Prepare regulatory impact assessments and communicate significant changes to relevant stakeholders.
Maintain regulatory obligation registers, submission trackers, approval records, renewal calendars, and compliance documentation.
Coordinate the preparation, review, submission, and maintenance of regulatory applications and supporting documentation.
Ensure that regulatory submissions are accurate, complete, consistent, properly formatted, and submitted within established timelines.
Compile technical documentation, product information, certificates, declarations, specifications, and other required submission materials.
Review regulatory dossiers for completeness, traceability, scientific accuracy, and alignment with applicable submission requirements.
Coordinate with internal subject-matter experts to obtain technical, quality, clinical, safety, and manufacturing information required for regulatory submissions.
Support the preparation and maintenance of product registration applications and related regulatory records where applicable.
Manage regulatory submission schedules and communicate deadlines, dependencies, and outstanding documentation requirements.
Monitor application progress and coordinate responses to questions, deficiencies, requests for clarification, and additional information requirements.
Liaise with relevant regulatory authorities and authorized representatives regarding submission status, documentation requests, and approval matters.
Maintain accurate records of regulatory correspondence, submission receipts, authority feedback, decisions, and approval conditions.
Coordinate product license renewals, registration maintenance, certificate updates, and other periodic regulatory obligations.
Track license expiry dates and initiate renewal activities sufficiently in advance of applicable deadlines.
Review proposed product changes to determine whether regulatory notifications, variations, amendments, or approvals may be required.
Assess the regulatory implications of changes to product composition, specifications, labeling, packaging, manufacturing sites, suppliers, and production processes.
Coordinate change control activities with Quality Assurance, Manufacturing, Engineering, Procurement, and other relevant departments.
Ensure that regulatory commitments and approval conditions are incorporated into applicable operational procedures.
Review product labeling, packaging artwork, instructions for use, product inserts, and promotional materials for regulatory consistency where applicable.
Verify that product claims, indications, warnings, contraindications, and safety statements align with approved information and relevant requirements.
Coordinate labeling reviews with Medical Affairs, Pharmacovigilance, Quality Assurance, Legal, and Marketing teams.
Support the assessment of regulatory requirements for new products, product extensions, new markets, and business expansion initiatives.
Conduct preliminary regulatory feasibility assessments to identify approval requirements, potential barriers, and documentation needs.
Maintain regulatory intelligence on competitor developments, industry trends, emerging standards, and evolving approval pathways.
Support regulatory strategy development for assigned products, services, and operational initiatives.
Coordinate regulatory planning with project teams to ensure that compliance requirements are addressed at appropriate project stages.
Review technical and quality documentation related to manufacturing, testing, storage, distribution, and product lifecycle management.
Support compliance with applicable Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP), and other relevant standards.
Work with Quality Assurance to maintain alignment between regulatory commitments, quality management systems, and controlled procedures.
Assist in the preparation and maintenance of technical files, quality documentation, declarations of conformity, and supporting evidence where applicable.
Coordinate the collection and verification of product specifications, test reports, validation records, certificates, and manufacturing documentation.
Evaluate regulatory documentation supplied by manufacturers, distributors, consultants, and external service providers.
Support the qualification and oversight of regulatory consultants, authorized representatives, and third-party service providers.
Collaborate with Procurement and Contract Management teams to incorporate appropriate regulatory obligations into supplier and service agreements.
Review supplier changes, manufacturing site changes, and outsourced activities for potential regulatory impact.
Maintain a structured archive of approved submissions, regulatory decisions, product licenses, and supporting records.
Ensure that controlled regulatory documents remain current, traceable, accessible to authorized personnel, and protected against unauthorized modification.
Support document control activities involving version management, approval workflows, retention requirements, and audit trails.
Participate in internal audits, external assessments, and regulatory inspections relating to assigned responsibilities.
Coordinate the preparation of audit evidence, regulatory files, approval records, and responses to inspection requests.
Support inspection readiness by identifying documentation gaps and coordinating timely remediation.
Investigate regulatory compliance deviations, submission errors, missed deadlines, and documentation discrepancies.
Conduct root cause analysis and support the development of corrective and preventive action (CAPA) plans.
Monitor CAPA implementation and verify that corrective actions address identified regulatory deficiencies.
Escalate significant regulatory risks, potential noncompliance, and approval delays to the appropriate management personnel.
Coordinate with Pharmacovigilance teams on applicable safety reporting requirements, safety-related regulatory submissions, and product information updates.
Support the review and submission of safety-related regulatory variations, risk management documentation, and post-market safety information where relevant.
Collaborate with Medical Affairs and Clinical Research teams to ensure that clinical and scientific documentation meets applicable regulatory requirements.
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Work arrangement
Yes