8 Disease areas. 95 NMEs. 45 associates worldwide. That is Regulatory Affairs Early Development in 2021. Novartis Institutes for Biomedical Sciences (NIBR) is world-renowned for its groundbreaking science in drug development including cell and gene therapy. We work closely with scientists in NIBR on innovative medicines in diseases with a high unmet medical need based on NIBRs scientific discoveries. As part of the NIBR team, Early Development Regulatory Managers contribute to bring innovative novel therapies to patients as quickly as possible. We are a culturally diverse, highly collaborative, curious and unbossed team who play a critical role planning for first in human and to optimize strategies from first in human to the development decision point, as well as contribute to the long-term strategy of the projects to registration in collaboration with RA colleagues in Global Drug Development. Read on to learn what you could do as part of our closely knit team and join us at the scientific frontier!
**This role can be based at either the East Hanover, NJ or Cambridge, MA sites**
Your responsibilities will include, but are not limited to: * Providing input into regulatory strategies and taking responsibility for their subsequent implementation. * Managing operational activities for assigned projects and regions in accordance with applicable regulatory standards and within appropriate timeframes. * Representing Regulatory Affairs and leading sub-teams and/or cross-functional teams as required * Health Authority interactions. * Contributing to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification. * Handling our internal systems and tools that are needed to assess compliance.