Regulatory Affairs Associate
Role Overview
A multinational pharmaceutical organization seeks a Regulatory Affairs professional for its Gulf Regulatory Affairs team.
The role supports regulatory operations, dossier compilation, submission tracking, labeling, and administrative coordination.
Key Skills for This Role
Full Job Posting
Contract
- The contract is 12 months and renewable.
- Employment is outsourced through Manpower Middle East.
About the role
A multinational pharmaceutical organization seeks a Regulatory Affairs professional for its Gulf Regulatory Affairs team.
The role supports regulatory operations, dossier compilation, submission tracking, labeling, and administrative coordination.
Regulatory responsibilities
- Support new product registrations, line extensions, and submissions for new indications.
- Execute license maintenance, including renewals, labeling updates, and CMC changes.
- Prepare and compile regulatory dossiers in compliance with local regulations.
- Maintain regulatory systems, archives, and documentation for compliance and audit readiness.
- Follow up with health authorities, distributors, and internal stakeholders to secure timely approvals.
- Support labeling activities and keep product information compliant and up to date.
- Assist with compliance initiatives, audits, and continuous process improvements.
Candidate requirements
- Bachelor's degree in Pharmacy.
- Fluent written and spoken English and Arabic.
- Strong communication, planning, and organizational skills; able to multitask and pay close attention to detail.
- Proficiency in computer applications and regulatory systems.
- Able to adapt to changing priorities and build strong stakeholder relationships.
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