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 Include, but are not limited to:
* Provide regulatory leadership to assigned project(s)
* Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans
* Ensure that Regional/CPO input is sought and incorporated into global regulatory strategy
* Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks
* Responsible for development and implementation of the global strategic regulatory plan
* Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of program changes/information to support timely communication to Health Authorities globally
* Partner with regions to align on strategy in order to fulfill business objectives
* Acquire timely consultation with RA line management and Novartis advisory boards on strategy