Regulatory Affairs & Quality Assurance Specialist (Arabic Speaker)

We are seeking a Regulatory Affairs & Quality Assurance Specialist to manage regulatory compliance and quality requirements across the company s product portfolio. The ideal candidate will have a strong understanding of medications and pharmaceutical products, with experience in pharmaceutical regulatory affairs, quality assurance, and SFDA requirements.

Key Responsibilities

• Prepare, review, and maintain regulatory documentation for product registrations, renewals, and submissions.

• Coordinate with the Saudi Food and Drug Authority (SFDA) on regulatory matters and follow up on submissions.

• Monitor regulatory updates and assess their impact on the company s products and operations.

• Support compliance with Good Distribution Practice (GDP) across product storage, handling, and distribution.

• Maintain quality documentation, standard operating procedures, and accurate compliance records.

• Support quality audits, inspections, and the investigation of deviations and product complaints.

• Coordinate corrective and preventive actions and follow up on their implementation.

• Develop a thorough understanding of the product portfolio and its regulatory and quality requirements.

• 3 5 years of experience in pharmaceutical regulatory affairs and quality assurance.

• Strong understanding of medications and pharmaceutical products.

• Knowledge of SFDA requirements and Good Distribution Practice (GDP).

• Ability to quickly understand the company s product portfolio and related compliance requirements.

• Strong attention to detail, organizational skills, and documentation accuracy.

• Fluency in Arabic and English.