Regulatory Affairs Assistant

About the role

Our client, a leading multinational pharmaceutical organization, is looking for a Regulatory Affairs Assistant to join its Gulf Regulatory Affairs team. The role involves supporting critical regulatory operations, dossier compilation, submission tracking, labeling activities and administrative coordination in a fast‑paced environment.

Key responsibilities

• Support new product registrations, line extensions and new indication submissions.
• Execute license maintenance activities such as renewals, labeling updates and CMC changes.
• Prepare and compile high‑quality regulatory dossiers in line with local regulations.
• Maintain regulatory systems, archives and documentation to ensure audit readiness.
• Follow up with health authorities, distributors and internal stakeholders to secure timely approvals.
• Assist with labeling activities to keep product information compliant.
• Contribute to regulatory compliance initiatives, audits and continuous process improvements.

Required profile

• Bachelor’s degree in Pharmacy.
• Strong communication, planning and organizational abilities.
• Excellent multitasking skills with a keen eye for detail.
• Proficiency in computer applications and regulatory systems.
• Fluent in English and Arabic, both written and spoken.
• Adaptability to changing priorities and ability to build strong stakeholder relationships.

Required skills

• Dossier compilation
• Computer Applications
• Regulatory operations
• Regulatory systems
• Labeling activities
• Regulatory Compliance
• Submission tracking