Regulatory Affairs Associate Jobs In Dubai UAE 2023 | Novartis
Found in: Talent AE 2A C2 - 2 weeks ago
Coordinate with project lead and stakeholders to assess and define projects scope, requirements and timelines for proper planning and execution.Act as a point of contact and communicate project status with countries.Coordinate with Logistics/ Supply Chain/ Labeling teams and manufacturing site to obtain valid artworks and implementation dates.Arrange and request all needed documents and certificates for files submission to Health Authorities.Prepare submission dossiers and publish eCTD as per countries requirements and regulations.Coordinate and follow-up with countries to ensure timely submission as per plan.Support countries in Health Authorities’ queries to secure speedy approvals.Update project trackers and proper archiving for documents and dossiers.Comply with all internal SOPs and trainings.
Requirements:
Bachelor’s degree in Pharmacy, Biology or Chemistry.2 years’ regulatory affairs experience in pharmaceutical industry.Good knowledge in Gulf/ levant regulatory requirements and compliance.eCTD experienceEffective planning and organizational skills to manage complex projects.Strong communication and negotiation skills.Team oriented personality.Fluent in English and Arabic.
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