150 plus global submissions ranging from INDs/CTAs to NDAs for you to be involved in your role as Submissions Manager as part of the Clinical Sciences & Innovation team within NIBR's Translational Medicine group.
The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. Within TM, Clinical Sciences and Innovation (CS&I) is a dynamic group of clinical scientists who plan and manage all NIBR's Phase I and Phase IIa clinical trials worldwide, ensuring they run smoothly, on time and most importantly with patients' interests to the fore.
In the Global Regulatory Submission Manager role your responsibilities will include but are not limited to:
Lead the global NIBR submission team and manage NIBR deliverables for submissions such as INDs, IMPDs and CTA, Health authority responses and annual reports.
Develop and track timelines for NIBR components of submissions by partnering with NIBR authors and contributors
Serve as the subject matter expert for the above submission activities and provide guidance to line functions.
Support senior team members on NDAs and MAAs.
Position can be based in East Hanover, NJ or Basel, Switzerland