Regulatory Affairs Executive

Roles & Responsibilities:
• Prepare and compile CTD dossiers for pharmaceutical product registration and renewals in the UAE.
• Ensure full compliance with UAE MOH regulations and regulatory guidelines.
• Monitor and stay updated on regulatory requirements for pharmaceutical products.
• Coordinate with internal teams on documentation, labeling, and submission activities.
• Support pharmacovigilance activities including adverse event reporting.
• Liaise with UAE MOH and other regulatory authorities for approvals, queries, and follow-ups.
• Assist during regulatory audits and inspections.
• Maintain accurate records of submissions, approvals, and regulatory correspondence.

Qualification:
• B.Pharmacy or D.Pharmacy

Experience:
• Minimum 2 years of experience in the UAE pharmaceutical industry.
• Hands-on experience in CTD dossier preparation and submissions.
• Working knowledge of UAE MOH regulations and pharmacovigilance requirements.

Skills:
• Strong understanding of UAE regulatory frameworks and CTD documentation.
• Good coordination and communication skills.
• High attention to detail and compliance orientation.
• Ability to manage multiple submissions and deadlines.
• Proficiency in documentation and record management.

About the Organisation:
Microsynergy Pharmaceuticals is a pharmaceutical company focused on regulatory compliance, product registration, and lifecycle management, supporting the timely approval and safe marketing of pharmaceutical products within the UAE market.