Novartis
Global Regulatory Submission Manager
This job is now closed
Job Description
- Req#: 372437BR
1,800+ associates. 85+ countries. 1 goal. At Novartis, we are dedicated to discovering and developing new treatments for diseases including cancer, heart disease, and neurological conditions—and delivering them at a scale to reach as many patients as possible. Novartis has a unique and promising portfolio with approximately 70 projects as potential NMEs in development, 52 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. And you could be at the center of it all in Regulatory Affairs (RA), where your voice, experience, and quality mindset can truly make a difference in drug development at Novartis. Read on to learn about the role available in RA. We hope you will consider joining our global RA family.
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 efficienciesAbout the company
At Novartis, we are reimagining medicine to improve and extend people’s lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Learn mo...
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