Job 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.
We are looking for a Regulatory Affairs Associate to join our team in UAE. The role will be an External 3rd Party Contractor for a period of 18 months contract.
The role is to provide effective regulatory support to Gulf/ Levant for NTO/ Site transfer projects, regulatory maintenance, and regulatory compliance activities.
The major accountabilities of the role are defined below:
• 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.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
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.
Division
Global Drug Development
Business Unit
REG AFFAIRS GDD
Location
Utd.Arab Emir.
Site
Dubai
Company / Legal Entity
NOV MIDDLE EAST FZA UAE
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Temporary
Shift Work
No
