Regulatory Coordinator

5 days ago

Manama, Manama, Bahrain Cigalah Gulf Medical Full time 30,000 - 360,000 per year

Job Opening: Regulatory Affairs Officer / Coordinator

Location: Kingdom of Bahrain

We are looking for a Regulatory Affairs Officer / Coordinator to join our growing pharmaceutical team. The ideal candidate will play a key role in ensuring our company's full compliance with NHRA regulatory requirements, supporting product registrations, renewals, and quality-related operations.

Qualifications & Requirements:

  • Bachelor's Degree in Pharmacy (BS Pharmacy)
  • Must possess a valid NHRA license (Bahrain)
  • 4–5 years of proven experience in Regulatory Affairs within the pharmaceutical industry
  • Solid understanding of NHRA and GCC regulatory guidelines and procedures
  • Experience in Quality Assurance (QA), Quality Systems, and Regulatory Compliance
  • Excellent knowledge of dossier preparation, submission, and tracking
  • Strong organizational and documentation skills with keen attention to detail
  • Good communication and interpersonal skills
  • Must be currently residing in Bahrain
  • Able to join immediately

Key Responsibilities:

  • Prepare, compile, and review regulatory dossiers for product registration, renewals, and variations in compliance with NHRA/GCC requirements
  • Liaise effectively with NHRA officials and other health authorities to ensure timely approvals
  • Maintain and update product licenses, certificates, and technical documentation
  • Ensure regulatory compliance for all marketed pharmaceutical products
  • Support internal and external audits, quality reviews, and inspection readiness activities
  • Collaborate with cross-functional departments (QA, Supply Chain, Production, etc.) to ensure adherence to company and regulatory standards
  • Stay up to date with changing regulations, guidelines, and industry trends affecting product registration and compliance

Job Type: Full-time

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