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Job Post Details

Regulatory Affairs Specialist
From AED12,000 a month
Permanent, Full-time

Job details

From AED12,000 a month
Permanent, Full-time
Dubai

Full job description

Requirements

  • Bachelor’s degree in Pharmacy, Pharmaceutical Sciences or a related life-science field. A UAE pharmacist licence is an advantage.
  • At least 5 years of hands-on regulatory affairs experience registering conventional pharmaceutical products in the UAE.
  • A proven record of successful MOHAP/EDE submissions and approvals.
  • Strong working knowledge of CTD/eCTD dossier structure, UAE registration guidelines and pricing procedures.
  • Strong analytical and critical problem-solving skills, with the ability to resolve complex regulatory issues on your own.
  • Experience drafting responses to regulatory queries and negotiating with authorities.
  • Excellent written and spoken English. Arabic is an advantage.
  • Highly organised and detail-oriented, able to manage several submissions at once.

Key responsibilities

  • Manage the full registration process for conventional pharmaceutical products with MOHAP / Emirates Drug Establishment (EDE), from dossier receipt to final approval.
  • Review and analyse CTD/eCTD dossiers (Modules 1–5) for completeness, compliance and gaps. Coordinate with manufacturers to fix any deficiencies before submission.
  • Prepare and submit new registration applications through the official portals.
  • Product lifecycle management: Maintain registered products throughout their lifecycle. This covers renewals, variations (Type I/II, CMC, labelling and safety updates), site or manufacturer transfers, change of marketing authorisation holder, and withdrawals. Keep every registration current and compliant from approval until discontinuation.
  • Handle MOH queries and deficiency letters, and write clear, technically sound responses within deadlines.
  • Assess and handle pricing submissions, GMP/site registration and company registration requirements as needed.
  • Keep accurate regulatory trackers covering submission status, approval timelines, renewals and expiries.
  • Track changes to UAE regulations and guidelines, and advise management on what they mean for the product pipeline.
  • Review artwork, labels and patient information leaflets against UAE requirements.
  • Work with suppliers, principals and internal teams to keep registrations on schedule and support product launches.

Pay: From AED12,000.00 per month

Work Location: In person

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