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Regulatory Affairs & Quality Assurance Specialist (Arabic Speaker)

Besst Group > Jobs > Quality Assurance > Regulatory Affairs & Quality Assurance Specialist (Arabic Speaker)

Job Description

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.

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.

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