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Job ID : 203973BR
Position Title : Manager RA, GDD – India
Division : Global Drug Development
Business Unit : REG AFFAIRS GDD
Work Location : Mumbai
Job Description :
The registration of new drug products and the maintenance of registration of approved drug products in order to ensure viability of these products in the marketplace
New Product Registrations – 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 Maintenance of registered products – With minimum supervision, maintain registration of currently approved products Product Information
and Consumer Information – With minimum supervision, develop and maintain product information and consumer information ensuring the correct distribution and use of the approved versions of these documents Review of Promotional Material – Review promotional material for assigned products Company Licences and Pure Substance– Responsible for the maintenance and implementation of relevant importation and exportation licenses and the co-ordination of pure substance requests 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 and industry bodies, such as the APMA. Provide valuable regulatory advice as necessary. Assist Medical Information and Quality Assurance with product detail requests wherever feasible. Assist Training Manager with Product Information training requirements wherever feasible Provide adequate training and guidance to all junior regulatory associates as requested by DRA Manager.Minimum requirements : Pharmacy or Science (majoring in a life science or chemistry) with or without postgraduate qualifications English and country language 2-3 years experience as an associate in regulatory affairs dealing with a wide variety of registration projects and issues.
