Regulatory Affairs Officer

About the Role

We're seeking a Regulatory Affairs Officer to manage product registrations and compliance for our generic pharmaceutical distribution operations in Dubai. You'll be the key liaison between our principal companies, regulatory authorities (DHA/MOH), and internal teams, ensuring all dossiers and submissions meet UAE regulatory standards. This is a hands-on role where your expertise directly impacts our ability to bring quality generic medicines to market efficiently.

Key Responsibilities

• Prepare, review, and submit eCTD/CTD dossiers and product registration files for generic medicines to DHA and MOH, ensuring compliance with all regulatory requirements
• Manage relationships with principal companies and coordinate product registration timelines, documentation requests, and regulatory correspondence
• Review and process herbal, GSL (General Sales List), and medical device files, maintaining detailed records and tracking submission status across all regulatory portals
• Navigate TAMM portal, DHA, Dubai Municipality, and other regulatory systems to submit applications, track approvals, and manage code assignments for registered products
• Conduct thorough dossier reviews for accuracy, completeness, and regulatory compliance before submission, identifying and resolving gaps with internal teams and principals
• Serve as the primary contact for MOH inquiries, deficiency notices, and regulatory communications, ensuring timely and accurate responses

Requirements

• Bachelor's degree in Pharmacy (B.Pharm) from an accredited institution
• Minimum 2 years of regulatory affairs experience specifically in pharmaceutical distribution (not manufacturing) in the UAE or GCC region
• Fluent in both Arabic and English (written and spoken) — Arabic proficiency is essential for MOH interactions
• Proven experience with generic product registrations and familiarity with UAE regulatory frameworks (DHA/MOH licensing and approval processes)
• Strong proficiency with eCTD/CTD dossiers, TAMM portal, and other UAE regulatory submission systems
• Exceptional attention to detail, organizational skills, and ability to manage multiple registration files simultaneously
• Nice to have: Experience with herbal and medical device regulatory pathways; familiarity with Gulf pharmaceutical distributors (Gulf Drugs, similar companies)