Regulatory Affairs Officer

Overview

Regulatory Affairs Associate

Key Responsibilities

• Manage registration and lifecycle submissions for multiple product categories (Conventional medicines, GSL, Medical Devices, Cosmetics, Food Items) across UAE authorities, including:
• EDE, Dubai Municipality (Healthy Consumer Section), Dubai Municipality (Food Department), and relevant standards/competent authorities (e.g., ESMA legacy requirements where applicable).
• Receive, review, and submit regulatory files for: new registrations, renewals, variations (minor/major as applicable), classification, repricing, endorsement, cancellation, and updates related to patency/exclusivity and dispensing status.
• Handle submissions related to MAH and manufacturing site registration/renewal/variations, as applicable.
• Perform document completeness and compliance checks and communicate deficiencies to principal companies with clear corrective guidance.
• Coordinate with principal companies on Module 1 preparation in line with UAE requirements.
• Track renewal timelines proactively to avoid delays and ensure continuity of importation/supply; escalate risks early.
• Coordinate EDE Quality Control Laboratory submissions (quality documents and/or samples), follow up on technical requirements, and support until final analysis approval.
• Manage post-submission activities: receive authority comments, coordinate responses with principals, and ensure timely resubmissions.
• Receive and circulate approval certificates internally and to principal companies; maintain regulatory trackers and records.
• Monitor and communicate new circulars, ministerial decrees, and regulatory updates impacting the portfolio.
• Maintain professional relationships with Drug Department / authority stakeholders and support urgent cases (e.g., shipment release support where regulatory clarification is required).
• Support principal-company meetings and alignment on current/future projects and authority expectations.
• Provide cross-functional support to internal teams when required.

Requirements

• **Bachelor’s Degree in Pharmacy (mandatory)**
• 2-3 years of experience in Regulatory Affairs in the UAE (similar role and scope)
• Strong knowledge of UAE regulatory pathways and authority expectations
• Strong planning, organization, and documentation discipline
• Excellent communication and stakeholder management skills
• Good computer skills and ability to manage multiple trackers/submissions in parallel.