Job Description
769 million lives touched by our products. Imagine what you could do at Novartis. No matter where you work, you could contribute to solving some of the toughest healthcare challenges and have an extraordinary impact on people’s lives. Join us!
We are looking for a Regulatory Affairs Associate to join our team based in UAE. The purpose of the role will be towards registration of new drug products, the maintenance of registration of approved drug products and the maintenance of RA-GDD compliance KPIs as per Novartis guidance in order to ensure viability of these products in the marketplace.
Major Accountabilities of the role are as defined below.
• New Product Registrations – With supervision, evaluate, and prepare drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favourable outcome
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• Close FU internally, with supervision, to reply to the enquiries received from the HA about the variations and renewal applications
• Coordinate with 3rd party suppliers for reference / related substance requests from the MOH.
• Initiate and prepare, with supervision, new or renewal registration of manufacturing site as per new and mature products registration plan in the assigned countries.
• Update local archives for manufacturing site new/renewal, variation update, renewal update
• Coordinate with RA-GDD manager/head to ensure correct and speedy implementation / consignments as per the approved applications (variation/ renewal/ site transfer/ site registration/leaflet update).
• Maintain the internal RA-GDD database accurate and updated: Dragon
• Comply with all the mandatory RA-GDD training and Maintain updated records of RA-GDD training/compliance training
• Product Information – With supervision, develop and maintain product information ( LEAFLET UPDATE) ensuring the correct distribution and use of the approved versions of these documents
• Relationships within and outside the company – Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with health authority.
• With Supervision, Review PPMS and ensure AQWA Launch request are prepared and launched on time.
• With Supervision, Ensure full support to Global regulatory compliance initiatives including:
– Dragon /RA-GDD database updates and verification.
– Registration and implementation of labelling changes.
– Preparation for Submission of Risk Management plans (RMP) and Periodic Safety Update Reports (PSURs).
– Ensure preparation for submission of new Safety updates received from RA-GDD Global.
• With Supervision, Update logistics with the RA-GDD related information for the completion of Notification of Introduction (NOI).
• Monthly reporting of the activity to the RA-GDD Manager/Head
• Assist Medical Information and Quality Assurance with product detail requests wherever feasible. Assist Training Manager with Product Information training requirements wherever feasible.
• Request all required documentation concerning manufacturing site registration from Basel and support team in India
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements
Education: Tertiary qualified – Pharmacy or Science (majoring in a life science or chemistry) with or without postgraduate qualifications
Languages: Arabic and English written and spoken are mandatory.
Experience: 1-3 years’ experience as an associate in regulatory affairs dealing with a wide variety of registration projects and issues.
Strong preference will be for UAE Nationals.
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
Regular
Shift Work
No
