Regulatory Affairs Manager Jobs in Dubai | Novartis

Regulatory Affairs Manager Jobs in Dubai | Novartis

Job Responsibilities:

• Implementing the registration of priority / new products in Gulf as per the agreed yearly objectives. With minimum supervision, evaluate, prepare and submit drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favourable outcome for registration and pricing.
• Coordinate with Global Program Regulatory Managers (GPRMs) and supporting team in Hyderabad to ensure having the registration requirements on time, hence fast submission / approval of new products.
• Coordinate with 3rd party suppliers for reference / related substance requests from the MOH.
• Ensure new/renewal of registration of manufacturing site as per new and mature products registration plan in the assigned countries
• Request all required documentation concerning manufacturing site registration from Basel and support team in India
• Ensure speedy submissions and approvals of manufacturing site registration in the assigned countries in order to shorten time of product registration
• Update local archives for manufacturing site new/renewal of registrations
• Coordinate with maintenance group Team Leader to ensure correct and speedy implementation / consignments
• Develop and maintain good working relationship with RA-GDD Team in Middle East Cluster and Indian RA-GDD support team
• Develop and maintain strong relationship with the Health Authorities and Agents in the assigned countries
• Provide necessary supports to the responsible parties of the acquired companies for the Novartis products divested to them.
• Provide necessary maintenances (CMC/PT/Renewals) to the divested products until the divestment process is completed
• Necessary follow-ups until the Marketing Authorization of the divested product is transferred to the new company