Global Program Regulatory Manager / Sr -Transplant & Rheumatology
Location: East Hanover, New Jersey
Internal Number: 326704BR
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. 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 Immunology, Dermatology and Hepatology development team you will be able to contribute efforts towards the successful drug development of therapies, achieve health authorities' approvals and enable patients' access to new treatment options. The responsibility is for programs in transplant and rheumatology to develop therapies in these disease areas.
Your responsibilities include: * Provide input into regulatory strategies and take responsibility for their subsequent implementation * Manage operational activities for assigned projects and regions in accordance with applicable regulatory standards and within appropriate timeframes * Represent Regulatory Affairs and lead sub-teams and/or cross-functional teams as required * Coordinate or lead (in some circumstances) Health Authority meetings in assigned region(s) * Contribute to the development of global and local labelling 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