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Regulatory Affairs

Company:
Bahrain Recruit
Location:
Manama, Capital Governorate, Bahrain
Posted:
April 24, 2025
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Description:

About the Role: A well-established company in the pharmaceutical, medical device, and FMCG sectors is seeking a motivated and detail-oriented Regulatory Affairs Professional to join its team in Bahrain.

This role is essential in ensuring regulatory compliance and managing product registrations across Bahrain and the GCC region.

Key Responsibilities: Prepare, compile, and submit product registration dossiers to the NHRA and other relevant GCC regulatory authorities.

Stay up to date with local and regional regulatory requirements, and communicate changes to internal stakeholders.

Serve as the main point of contact with local regulatory bodies, particularly the NHRA.

Maintain accurate records of submissions, approvals, renewals, and official correspondence.

Review and approve product labels, marketing materials, and technical documents to ensure regulatory compliance.

Provide support during audits, inspections, and other regulatory reviews.

Collaborate with internal departments such as Quality Assurance and Pharmacovigilance.

Qualifications: Bachelor’s degree in Pharmacy, Biomedical, Chemistry, or a related field.

2–4 years of regulatory affairs experience in Bahrain, ideally within the pharmaceutical, medical device, or FMCG industries.

Strong knowledge of NHRA regulations and GCC registration procedures.

NHRA license and/or RAO (Regulatory Affairs Officer) license is a strong advantage.

Excellent written and verbal communication skills.

Fluency in English is required; Arabic is an added benefit.

Ability to manage multiple priorities and deadlines in a dynamic environment.

Please send your resume/CV

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