Regulatory Affairs Officer - UAE Dossier & Submissions Lead

LIFEPharma; Dubai; On-site; AED 150,000 - 190,000; Full time

Job summary

LIFEPharma in the UAE is seeking a motivated Regulatory Affairs Officer / Senior Officer to join the Regulatory Affairs team. The role focuses on preparing, reviewing, and submitting regulatory dossiers, supporting registrations, renewals, and variations for UAE health authorities, and coordinating communications with QA, QC, and other departments.

The ideal candidate has 3-5 years in pharmaceutical regulatory affairs, a Bachelor's degree in Pharmacy, and strong Arabic language skills.

Qualifications

• 3-5 years in Pharmaceutical Regulatory Affairs.
• Bachelor's Degree in Pharmacy.
• Arabic: Fluency strongly preferred.

Responsibilities

• Prepare, compile, review, and submit regulatory dossiers for pharmaceutical products.
• Support product registration, renewals, variations, and other regulatory submissions to UAE health authorities.
• Coordinate responses to regulatory authority queries and deficiencies.
• Review regulatory documents for completeness, accuracy, consistency, and compliance.
• Prepare and review product information, PILs, package inserts, labeling, and artwork.
• Translate pharmaceutical leaflets, PILs, labeling, and regulatory documents from English to Arabic using accurate medical terminology.
• Review Arabic translations for accuracy, consistency, readability, and alignment with approved English versions.
• Coordinate with QA, QC, Production, Supply Chain, Medical Affairs, and Business Development teams.
• Maintain regulatory submission trackers, registration records, certificates, approvals, and authority correspondence.
• Support regulatory activities for GCC and international markets.
• Ensure submissions, responses, follow-ups, and regulatory documentation are completed within agreed timelines.

Skills

Regulatory affairs

Education

Bachelor's degree in Pharmacy

Job description

LIFEPharma in the UAE is seeking a motivated Regulatory Affairs Officer / Senior Officer to join the Regulatory Affairs team. The role focuses on preparing, reviewing, and submitting regulatory dossiers, supporting registrations, renewals, and variations for UAE health authorities, and coordinating communications with QA, QC, and other departments.

The ideal candidate has 3-5 years in pharmaceutical regulatory affairs, a Bachelor's degree in Pharmacy, and strong Arabic language skills.