Regulatory Affairs Associate

Manpower Middle East

United Arab Emirates

Presencial

AED 120.000 - 180.000

Jornada completa

Hace 4 días
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Descripción de la vacante

Manpower Middle East is seeking a Regulatory Assistant to join the Gulf Regulatory Affairs team on a 12-month outsource contract. You will assist in regulatory operations, dossier compilation, submission tracking, labeling activities, and coordination with stakeholders in a fast-paced environment.

The ideal candidate holds a Pharmacy degree, demonstrates excellent organizational skills, and can manage multiple priorities effectively while communicating across English and Arabic.

Formación

  • Bachelor's Degree in Pharmacy or equivalent.
  • Strong communication, planning, and organizational skills.
  • Excellent multitasking abilities with attention to 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 stakeholder relationships.

Responsabilidades

  • Support regulatory operations, dossier compilation, and submission tracking.
  • Maintain regulatory systems, archives and documentation for audit readiness.
  • Coordinate labeling activities and regulatory considerations for products.
  • Follow up with health authorities, distributors, and internal stakeholders to obtain approvals.

Conocimientos

Communication
Planning
Organization
Multitasking
Regulatory systems
English & Arabic
Stakeholder management

Educación

Bachelor's degree in Pharmacy

Herramientas

Regulatory software

Descripción del empleo

Contract: 12 months (renewable)

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.
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