Junior Regulatory Affairs Specialist — Pharmaceuticals & Medical Devices
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Key skills for this role
About the Role
MRG seeks a Junior Regulatory Affairs Specialist to support pharmaceutical and medical device registrations in the UAE. You will prepare dossiers, track applications, and communicate with authorities and clients.
Key Skills for This Role
Responsibilities
- Prepare and compile drug registration dossiers (CTD format) for submission to UAE health authorities
- 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
- 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)
- Fluent English (written and spoken) — required
- 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
- Arabic is a strong plus
- Based in Dubai or able to relocate
Full Job Posting
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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