Regulatory Affairs Associate

A leading multinational pharmaceutical organization is seeking a Regulatory Assistant to support its Gulf Regulatory Affairs team. The role focuses on product registrations, regulatory dossier preparation, submission tracking, labelling activities, and compliance documentation in a fast-paced pharmaceutical environment.

Key Requirements

Bachelor’s degree in Pharmacy.

Fluency in English and Arabic, both written and spoken.

Strong organizational, planning, and communication skills.

Excellent attention to detail and ability to manage multiple priorities.

Proficiency in computer applications and regulatory systems.

Ability to coordinate effectively with health authorities, distributors, and internal stakeholders.

Key Responsibilities

Support new product registrations, line extensions, and new indication submissions.

Prepare and compile regulatory dossiers in line with local regulations.

Manage licence renewals, labelling updates, and CMC changes.

Maintain regulatory documentation, archives, and systems for audit readiness.

Follow up on submissions and approvals with relevant stakeholders.

Support regulatory audits, compliance initiatives, and process improvements.