Senior Global Program Regulatory Manager (Radioligand Therapy)
Location: East Hanover, New Jersey
Internal Number: 326338BR
26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.
We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever--OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Joining the oncology development team you will be able to contribute efforts towards the successful development of novel therapies or combination of therapies to fight cancer, achieve health authorities' approvals and enable patients' access to new treatment options to improve and extend their lives. Don't miss this opportunity to reimagine medicine!
Your responsibilities will include, but are not limited to: * Provide input into regulatory strategies for our innovative radioligand platform (a targeted radiotherapy, with radioligand imaging for patient selection) and take responsibility for their subsequent implementation under limited supervision - Act as FDA liaison for assigned radioligand products
* Manage operational activities for assigned radioligand projects and regions (focus US) in accordance with applicable regulatory standards and within appropriate timeframes
* Represent Regulatory Affairs and lead sub-teams and/or cross-functional teams as required
* Lead or coordinate Health Authority meetings in assigned region(s) (focus US)
* Contribute to the development of global and local labelling and review of promotional and non-promotional material in assigned region(s)
* Contribute to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification
* Handle internal systems and tools that are needed to assess compliance