Job Details
Novartis
Sr. Gbl Program Regulatory Manager (Assoc. Director)-Early Development
1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. Novartis Institutes for Biomedical Research (NIBR) is world renowned for its groundbreaking science in drug development including cell and gene therapies. RA plays a critical role planning first-in-human strategies through development decision point and long-term project strategy. We work closely with NIBR scientists on innovative medicines for diseases with a high unmet medical need. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.<br><br> <br>Your responsibilities will include, but are not limited to:<br><br>• Providing input into regulatory strategies and taking responsibility for their subsequent implementation.<br>• Managing operational activities for assigned projects and regions in accordance with applicable regulatory standards and within appropriate timeframes.<br>• Representing Regulatory Affairs and leading sub-teams and/or cross-functional teams as required<br>• Health Authority interactions.<br>• Contributing to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification.<br>• Handling our internal systems and tools that are needed to assess compliance<br><br>[#video#https://youtu.be/eLfyxqCvU5A{#400,300#}#/video#]