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