Regulatory Affairs Officer

About the role

A reputable local distributor is looking for an experienced Regulatory Affairs Associate to manage end-to-end regulatory submissions and lifecycle maintenance across multiple product categories and UAE authorities. The role works closely with principal companies and internal teams to ensure timely approvals, compliance and uninterrupted product supply.

Key responsibilities

• Manage registration and lifecycle submissions for conventional medicines, GSL, medical devices, cosmetics and food items with authorities such as EDE, Dubai Municipality (Healthy Consumer Section and Food Department) and other competent authorities.
• Receive, review and submit files for new registrations, renewals, minor and major variations, classification, repricing, endorsement, cancellation and updates on patency, exclusivity and dispensing status.
• Handle MAH and manufacturing site registration, renewal and variation submissions where applicable.
• Check document completeness and compliance, and communicate deficiencies to principal companies with clear corrective guidance.
• Coordinate with principal companies on Module 1 preparation under UAE requirements.
• Track renewal timelines proactively, escalate risks early and ensure continuity of importation and supply.
• Coordinate EDE Quality Control Laboratory submissions (documents and/or samples), follow up on technical requirements and support until final analysis approval.
• Manage post-submission activities: receive authority comments, coordinate responses and ensure timely resubmissions.
• Circulate approval certificates internally and to principal companies, maintain regulatory trackers and records, and monitor new circulars, ministerial decrees and regulatory updates.
• Maintain relationships with Drug Department and authority stakeholders, support urgent cases such as shipment release, and support principal-company meetings.

Required profile

• Bachelor's degree in Pharmacy (mandatory).
• 2-3 years of experience in Regulatory Affairs in the UAE in a similar role and scope.
• Strong knowledge of UAE regulatory pathways and authority expectations.

Required skills

• Planning, organization and documentation discipline.
• Excellent communication and stakeholder management skills.
• Good computer skills and ability to manage multiple trackers and submissions in parallel.