Regulatory Affairs Specialist

Regulatory Affairs Specialist wanted at a leading pharmaceutical industry in Dubai, UAE. Regulatory Affairs Specialist is responsible for ensuring that pharmaceutical products, food supplements, and medical devices comply with all applicable regulatory requirements across the Middle East region. The successful candidate with pharmacy or biotech background will manage product registrations, maintain regulatory approvals, coordinate with health authorities, and work closely with global and regional regulatory teams to ensure uninterrupted business operations.

The role requires strong knowledge of regional regulatory frameworks, excellent documentation skills, and the ability to manage multiple regulatory projects simultaneously.

Key Responsibilities

• Prepare and compile regulatory dossiers for new product registrations in accordance with country-specific regulatory guidelines.
• Manage product registrations for pharmaceuticals, food supplements, and medical devices across Middle East markets.
• Prepare and submit regulatory variations, renewals, amendments, and product updates to local health authorities.
• Ensure all regulatory submissions are completed accurately and within required timelines.
• Monitor changes in regional regulatory requirements and evaluate their impact on existing products.
• Coordinate with local regulatory authorities to obtain approvals and resolve regulatory issues.

• Develop, review, and maintain product labeling and artwork in compliance with country regulations.
• Review promotional materials and marketing content to ensure compliance with local advertising regulations.
• Support approval of promotional materials from health authorities whenever required.
• Collaborate with Global, EMEA, MEA, and local Regulatory Affairs teams on assigned projects.
• Provide regular reports on regulatory submissions, approvals, regulatory updates, and compliance status.
• Support cross-functional departments including Quality Assurance, Supply Chain, Commercial, and Marketing on regulatory requirements.

• Coordinate with distributors, authorized representatives, and external service providers across the region.
• Track registration timelines, renewals, approvals, and regulatory commitments.
• Maintain regulatory databases, documentation, archiving systems, and tracking tools in accordance with company procedures.
• Ensure complete and accurate maintenance of regulatory files and product documentation.

Required Qualifications

• Bachelor’s degree in Pharmacy, Life Sciences, or a related scientific discipline.
• 2–4 years of regulatory affairs experience within the pharmaceutical and medical device industry.
• Hands-on experience with product registration and regulatory lifecycle management.
• Strong understanding of Middle East regulatory requirements for pharmaceuticals and medical devices.
• Experience preparing regulatory dossiers, renewals, variations, and product submissions.
• Fluency in English and Arabic, both written and spoken.
• French language skills are considered an added advantage.
• Excellent organizational, documentation, and record-management skills.
• Strong analytical and problem-solving abilities.
• Excellent communication and stakeholder management skills.
• Ability to work independently while collaborating effectively with cross-functional and international teams.
• High level of accuracy and attention to detail.

Preferred Skills

• Pharmaceutical Regulatory Affairs
• Medical Device Registration
• Product Registration
• Regulatory Compliance
• Lifecycle Management
• GCC Regulatory Affairs
• Middle East Health Authorities
• Labeling Compliance
• Artwork Review
• Regulatory Documentation
• Variation and Renewal Submissions
• Quality Compliance
• Healthcare Regulations
• Cross-functional Collaboration
• Regulatory Strategy