Regulatory Affairs Manager Jobs in Dubai | Novartis

4 weeks ago


dubai, United Arab Emirates Novartis Full time
Regulatory Affairs Manager Jobs in Dubai | NovartisJob 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 countriesRequest all required documentation concerning manufacturing site registration from Basel and support team in IndiaEnsure speedy submissions and approvals of manufacturing site registration in the assigned countries in order to shorten time of product registrationUpdate local archives for manufacturing site new/renewal of registrationsCoordinate with maintenance group Team Leader to ensure correct and speedy implementation / consignmentsDevelop and maintain good working relationship with RA-GDD Team in Middle East Cluster and Indian RA-GDD support teamDevelop and maintain strong relationship with the Health Authorities and Agents in the assigned countriesProvide 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 completedNecessary follow-ups until the Marketing Authorization of the divested product is transferred to the new company
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