Junior Regulatory Affairs Specialist – Pharma & Med Devices

About the role

We are looking for a Junior Regulatory Affairs Specialist to support pharmaceutical and medical device registration activities in the UAE, based in our Dubai office. The role involves preparing dossiers, tracking submissions and liaising with health authorities under senior guidance.

Key responsibilities

• Prepare and compile drug registration dossiers (CTD format) for UAE health authorities (Emirates Drug Establishment / MOHAP).
• Support medical device registrations with MOHAP, including device classification, technical file preparation and importer/distributor requirements.
• Handle product lifecycle activities such as renewals, variations, artwork/labeling updates and responses to authority queries.
• Maintain registration trackers, submission records and document archives.
• Coordinate with international clients to collect technical documents, CPPs, GMP certificates and legalized documents.
• Support pharmacovigilance activities, including adverse event intake, reporting and safety documentation.
• Monitor UAE and GCC regulatory updates, circulars and guideline changes and summarise them for the team.
• Assist senior specialists and management with regulatory strategy research and client reports.

Required profile

• Bachelor's degree in Pharmacy (B.Pharm or PharmD) – required.
• Licensed pharmacist with a valid UAE pharmacist license (MOHAP, DHA or DoH) – required.
• 1–3 years of experience in pharmaceutical or medical device regulatory affairs, pharmacovigilance or a related role (fresh graduates with strong internships considered).
• Working knowledge of CTD structure and GCC/ICH guidelines is a plus; exposure to medical device regulations (UAE MOHAP, EU MDR, GHTF/IMDRF) is a plus.
• Fluent English (written and spoken) – required; Arabic is a strong plus.
• Strong attention to detail, organization and willingness to learn.
• Based in Dubai or able to relocate.

Required skills

• CTD dossier preparation.
• Knowledge of UAE MOHAP and Emirates Drug Establishment regulatory processes.
• Medical device classification and technical file preparation.
• Pharmacovigilance adverse event reporting.
• Familiarity with GCC/ICH guidelines.

What we offer

• Structured training and mentorship from senior regulatory professionals.
• Exposure to international manufacturers and multi‑market GCC registrations.
• Clear growth path within a fast‑growing regulatory consultancy.
• Competitive salary and benefits.