26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.
We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever--OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely knit team.
A position in Global Drug Development Regulatory Affairs Operations responsible for handling the delivery of cross functional submission documentation, being responsible for publishing activities and dispatch of compliant, worldwide regulatory submissions in support of Novartis global product portfolios.
Your Responsibilities include, but are not limited to: * Handles multiple and simultaneous global regulatory submission projects in eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, Compliance submissions, etc.]
* Drives cross-functional teams focused on the planning, compilation and dispatch of worldwide regulatory submissions, anticipating technical obstacles and developing solutions
* Provides guidance to project teams related to worldwide HA submission structure at/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows
* Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and coordinates internal review and approvals
* Partners with cross functional groups across the organization and contributes to operational activities and ongoing initiatives
* Effectively troubleshoots technical/quality issues relating to compilation, validation and dispatch of global submission outputs
* Assesses publishing resource and support needs and develops/implements solutions to create efficiencies