Posted:
Trious Pharma LLC is seeking a motivated and detail-oriented Executive – Regulatory Affairs to join its expanding team in Dubai. This is an excellent opportunity for professionals with experience in pharmaceutical and healthcare regulatory processes who are looking to grow their careers in a dynamic and fast-paced environment.
The successful candidate will be responsible for preparing regulatory submissions, managing product registrations, maintaining compliance documentation, and coordinating with manufacturers, clients, and UAE regulatory authorities. The role also involves monitoring regulatory updates and ensuring products continue to meet all applicable compliance requirements.
Key Responsibilities:
• Prepare and submit regulatory applications for pharmaceutical products, medical devices, health supplements, and cosmetics.
• Manage product classification, manufacturing site registration, and product registration with UAE regulatory authorities.
• Compile, review, and maintain regulatory dossiers and supporting documentation.
• Coordinate with manufacturers, clients, and regulatory authorities to resolve queries and obtain approvals.
• Review product artworks, labels, and technical documents to ensure regulatory compliance.
• Manage post-approval activities, including product variations, renewals, and amendments.
• Track the progress of regulatory submissions and provide regular status updates to clients and management.
• Stay updated on UAE regulatory guidelines and ensure compliance with changing requirements.
Requirements:
• Bachelor’s or Master’s Degree in Pharmacy, Life Sciences, or a related field.
• 2–4 years of experience in regulatory affairs.
• Experience with UAE pharmaceutical or healthcare regulatory processes is preferred.
• Good understanding of regulatory documentation and submission procedures.
• Excellent communication, coordination, and organizational skills.
• Strong written and spoken English language skills.
• Ability to manage multiple projects while meeting deadlines.
• Strong knowledge of:
• UAE Pharmaceutical and Healthcare Regulatory Processes.
• Regulatory Documentation, Product Registration, and Submission Procedures.
• Product Compliance, Label Review, and Post-Approval Regulatory Activities.
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