Contract: 12 months (renewable)
Employment: Outsourced through Manpower Middle East
About the Role:
Our client, a leading multinational pharmaceutical organization, is seeking a Regulatory Assistant to join their Gulf Regulatory Affairs team. As a Regulatory Assistant, you will support the Regulatory Team by managing critical regulatory operations, dossier compilation, submission tracking, labeling activities, and administrative coordination. The ideal candidate will have strong organizational skills, exceptional attention to detail, and the ability to manage multiple priorities effectively, enabling success in a fast-paced regulatory environment.
About the Requirements
- Support new product registrations, line extensions, and new indications submissions.
- Execute license maintenance activities including renewals, labeling updates, and CMC changes.
- Prepare and compile high-quality regulatory dossiers in compliance with local regulations.
- Maintain regulatory systems, archives, and documentation to ensure compliance and audit readiness.
- Follow up with health authorities, distributors, and internal stakeholders to secure timely approvals.
- Support labeling activities and ensure product information remains compliant and up to date.
- Assist with regulatory compliance initiatives, audits, and continuous process improvements.
About You:
- Bachelor's Degree in Pharmacy.
- Strong communication, planning, and organizational skills.
- Excellent multitasking abilities with a keen eye for detail.
- Proficiency in computer applications and regulatory systems.
- Fluent in English and Arabic, both written and spoken.
- Ability to adapt to changing priorities and build strong stakeholder relationships.
