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Sr Global Program Regulatory Manager (Cardio-Renal-Metabolic) (344926BR)





East Hanover, New Jersey, United States

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. 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 Sr GPRM will work independently under limited supervision to provide strategic and operational regulatory direction and may support the RA Global Program Team (GPT) representative and/or Global Therapeutic Area Lead (GTAL) for programs through development, registration and approval/post approval. The Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The Sr GPRM is a member of the RA sub team and may indirectly report to the RA GPT representative for the project and has responsibility for leading regional RA sub teams<br><br>Your accountabilities will include, but are not limited to: <br>• Provide input into global regulatory strategies and implement in assigned regions (focus US/LaCan) in collaboration with local teams <br>• Act as FDA liaison for assigned products<br>• Represent Regulatory Affairs and lead regulatory and cross-functional sub-teams<br>• Lead or coordinate Health Authority meetings<br>• Contribute to the development of global and local labeling and review of promotional and non-promotional material <br>• Ensure regulatory compliance, e.g. keep records of relevant Health Authority interactions in document management system and compliance databases<br><br>[#video#{#400,300#}#/video#]