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Junior Regulatory Affairs Specialist — Pharmaceuticals & Medical Devices

MRG
Dubai, UAE
Full Time
Entry
2 days ago
Regulatory AffairsCTD FormatPharmaceutical RegistrationMedical Device RegistrationPharmacovigilanceDocument Management
Free

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Regulatory AffairsCTD FormatPharmaceutical Registration
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About MRG

  • Medical Regulations Gate (MRG) is a leading regulatory affairs consultancy and Authorized Representative for pharmaceutical and medical device products across the GCC.
  • Growing Dubai office seeks a Junior Regulatory Affairs Specialist to support pharmaceutical registration activities in the UAE.

The Role

  • Support the regulatory team on pharmaceutical and medical device submissions to UAE health authorities.
  • Prepare dossiers and registration files, track applications, and communicate with authorities and clients under senior guidance.

Key Responsibilities

  • Prepare and compile drug registration dossiers (CTD format) for submission to UAE health authorities (Emirates Drug Establishment / MOHAP).
  • Support medical device registrations with MOHAP: device classification, technical file preparation, and importer/distributor requirements.
  • Support product lifecycle activities: 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: adverse event intake and reporting, and safety documentation.
  • Monitor UAE and GCC regulatory updates, circulars, and guideline changes and summarize for the team.
  • Assist senior specialists and management with regulatory strategy research and client reports.

Requirements

  • Bachelor's degree in Pharmacy (B.Pharm or PharmD) — required.
  • Licensed pharmacist — required. Must hold a valid UAE pharmacist license (MOHAP, DHA, or DoH).
  • 1–3 years of experience in pharmaceutical or medical device regulatory affairs, pharmacovigilance, or 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, or GHTF/IMDRF frameworks) 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.

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.

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