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Senior Manager RA , GDD

Novartis - Mumbai, Maharashtra - 268824BR Senior Manager RA , GDD - India Job Description Your responsibilities: Your responsibilities include , but are not limited to: 1.Develop and implement regulatory strategy for pipeline products. HA submission supervision for new drug applications , line extensions , manufacturing site registrations , clinical trial applications. 2.Oversee and advise on need - basis for all regulatory updates / compliances related to the various projects. 3.Oversee and advise on need - basis for licenses / NOCs pertaining to all types of clinical trial projects and RA India team. 4.Follow - up with local Head Public Affairs to monitor progress of various regulatory projects. 5.Oversee scrutiny and approval of regulatory aspects of artworks pertaining to new drugs. 6.Ensure adherence to various systems and databases in order to maintain compliance. 7.Advise RA Executive on product information maintenance and ensure update / implementation. 8.Significant participation in intra - depart...

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