Manager, Global Regulatory Affairs, CMC

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How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.Purpose:Execution of RA CMC activities for the preparation of technical regulatory documentation for new development and maintenance activities (MAs variations and renewals) and delivery of technical inputs to project teams members and others clients in GRA and in NCH OTC organization. Accountabilities:Provides, in close partnership with internal/external authors, all the necessary high quality technical documents for submission of new products or for accreditation and for geographical expansion of existing ones according to specific global or regional needs.Provides, in close partnership with technical information owners, appropriate documents for the maintenance of current portfolio (e.g. annual reports, variations files, QES). Supports RA affiliates in other GRA teams and in countries. Ensures in-time answers to all questions linked to CTD Module 3 during the evaluation of new application, renewals or varia-tion procedures.Delivers high quality technical regulatory support / advices to projects team (NCH & 3rd Par-ties) and implements all necessary RA CMC actions to deliver according to project plan.Works closely with RA CMC liaison to provide high quality inputs for ER and DR as well as with external partners (BD&L, TD) to evaluate new opportunities.Collaborates with QA associates, focuses on documentation compliance, and evaluates change requests in Trackwise.Delivers against allocated RA CMC tasks outside projects and participates actively in develop-ment and maintenance of GEMA CMC database.Works closely with Regulatory Operations team for the delivery of documents for e-submission.Implements RA CMC initiatives.May contribute to assigned special projects and activities within the team and may represent GRA in cross functional teams.
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