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. Read on to learn what you could do as part of our closely knit team.
** This role can either be based at the Cambridge, MA or East Hanover, NJ sites**
The Global Program Regulatory Director (GPRD) is a Regulatory Affairs leader, supporting Global Program Team(s) (GPTs). Functions independently with minimal supervision as a core member of the GPT to define and implement the global regulatory strategy for the development, submission, approval and life cycle management of the project(s), including drug, digital applications and medical devices, in close collaboration with the Global Therapeutic Area Lead (GTAL), as appropriate. Responsible for leading a high functioning global regulatory subteam(s) for the program. May also have full regulatory responsibility for one or more projects with little or no RA sub-team support as appropriate.
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 Regulatory Seed Document/ Regulatory Functional 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