Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Regulatory Affairs, Executive
Job Description
The executive will be responsible for 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 favorable 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.
Candidate Profile
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.
Additional Information
Experience : 2-3 years
Qualification : M.Pharm, M.Sc
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 30th December, 2019
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