Regulatory Affairs Associate

Manpower Middle East; Dubai; On-site; AED 100,000 - 179,000; Full time

Job summary

Manpower Middle East, on behalf of a leading multinational pharmaceutical organization in Dubai, is seeking a Regulatory Assistant to support the Gulf Regulatory Affairs team. You will manage regulatory operations, dossier compilation, submission tracking, labeling activities, and coordination with stakeholders.

The ideal candidate holds a Bachelor's in Pharmacy, fluent in English and Arabic, with strong organizational skills and the ability to handle multiple priorities in a fast-paced

Qualifications

• Bachelor's Degree in Pharmacy.
• Strong communication, planning, and organizational skills.
• Excellent multitasking abilities with attention to detail.
• Proficiency in computer applications and regulatory systems.

Responsibilities

• Support new product registrations, line extensions, and new indications submissions.
• Execute license maintenance activities including renewals and labeling updates.
• Prepare and compile regulatory dossiers in compliance with local regulations.
• Maintain regulatory systems, archives, and documentation for compliance and audits.
• Follow up with health authorities, distributors, and internal stakeholders to secure timely approvals.
• Assist with labeling activities and regulatory compliance initiatives.

Skills

Communication

Planning

Organization

Multitasking

Regulatory systems

English & Arabic

Stakeholder management

Education

Bachelor's degree in Pharmacy

Tools

Regulatory software

Job description

Employment: Outsourced through Manpower Middle East

About the Role:

Our client, a leading multinational pharmaceutical organization, is seeking a Regulatory Affairs professional 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.