Regulatory Affairs Associate Jobs In Dubai UAE 2023 | Novartis
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Novartis
Regulatory Affairs Associate Jobs In Dubai UAE 2023 | Novartis
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Description:
As a global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We’re committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
Responsibilities:
- 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 experience
- Effective planning and organizational skills to manage complex projects.
- Strong communication and negotiation skills.
- Team oriented personality.
- Fluent in English and Arabic.
To apply for this job please visit www.linkedin.com.
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