Regulatory Affairs & Quality Assurance Specialist (Arabic Speaker)

Client of Besst Group

Riyadh

On-site

SAR 120,000 - 180,000

Full time

10 days ago

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Job summary

Client of Besst Group in Riyadh, Saudi Arabia, seeks a Regulatory Affairs & Quality Assurance Specialist to manage regulatory compliance and quality requirements across the company’s product portfolio.

The ideal candidate will have 3-5 years of experience with SFDA regulations, GDP, and a strong understanding of pharmaceutical products. Arabic and English fluency is required for seamless cross-functional collaboration.

Qualifications

  • 3-5 years of experience in pharmaceutical regulatory affairs and quality assurance.
  • Knowledge of SFDA requirements and Good Distribution Practice (GDP).
  • Fluency in Arabic and English.

Responsibilities

  • Prepare review and maintain regulatory documentation for product registrations renewals and submissions.
  • Coordinate with the SFDA on regulatory matters and follow up on submissions.
  • Monitor regulatory updates and assess their impact on products and operations.
  • Support compliance with 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.

Skills

Regulatory affairs
Quality assurance
Arabic and English fluency
Attention to detail

Job description

We are seeking a Regulatory Affairs amp 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
Qualifications
  • 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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