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Senior Global Program Regulatory Manager (Life Cycle Management)




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><br>The Sr Global Program Regulatory Manager 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 responsibilities will include, but are not limited to:<br><br>• Implementing regulatory strategy and managing operational activities for a portfolio of products<br>• Independently managing preparation of regulatory submissions (e.g. Annual, aggregate safety reports, renewals, variations, etc.) for assigned portfolio<br>• Representing Regulatory Affairs and leading sub-teams and/or cross-functional teams as required for timely preparation of regulatory documents and serving as a primary contact with FDA for assigned portfolio of products<br>• Ensuring necessary updates and reviews of the prescription information and to maintain consistency with the CDS in collaboration with Global Labeling<br>• May serve as Regulatory Affairs subject matter expert<br>• May contribute to training and mentoring regulatory associates <br>• Contributing to portfolio streamlining activities e.g., pruning and de-registration, divestment – and drug shortage notifications<br>• Contributing to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification<br><br>[#video#{#400,300#}#/video#]