Sr. Global Labeling Manager

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. <br>We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.<br><br>The RA Senior Global Labeling Manager (Sr. GLM) is responsible for the creation and maintenance of regulatory compliant, competitive, and up-to-date core labeling documents for assigned developmental programs and Novartis Innovative Medicines products. The assigned products should be of higher complexity products and may include developmental programs. <br><br>The RA Sr. GLM provides strategic and operational regulatory labeling input and works in close collaboration with Expert Labeling Task Force (ELTF) members in creating or maintaining core labeling documents and handling HA or CO labeling queries for assigned products.<br><br>Your responsibilities will include but are not limited to:<br>• Serve as the labeling lead for all labeling related topics for Novartis products and development projects<br><br>• Coordinate and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate<br><br>• Lead and/contribute to presentations on labeling related topics for the assigned products at relevant board/forum/committee (e.g., GLC, SMT, MSRB, PSB)<br><br>• Contribute to global labeling management and continuous improvement initiatives, review and comment on emerging regulatory labeling guidelines<br><br>• Represent GL during audits and inspections<br><br>[#video#https://youtu.be/eLfyxqCvU5A{#400,300#}#/video#]