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.
A senior position in the GDD Regulatory Affairs Operations Regulatory Systems and Strategy group that is responsible for independently driving submission standards and strategies through interpretation and monitoring of worldwide HA regulatory requirements in support of the NVS global product portfolios.
Your responsibilities include, but are not limited:
* Lead and handle internal and cross-functional/cross-divisional groups/task forces on implementation of regulatory technical guidelines and new technology for submissions in new and emerging areas
* Chair/Lead global submission standard and strategy groups/forums
* Drive and participate in activities involving the creation and maintenance of submission process documentation, standards and strategies that will further improve submission preparation capabilities
* Actively monitor and interpret evolving HA requirements resulting in improved compliance and process efficiencies
* Represent Novartis on external committees e.g. trade associations, ad hoc groups, and speak at external conferences/workshops or industry meetings in area of expertise. Ensure Novartis priorities are included and addressed
* Comment on draft legislation/guidance, optimally shaping and influencing them via interactions with Authorities and Pharmaceutical Trade Organizations. Prepare interpretative analyses and impact of key regulatory documents related to global electronic submissions
* Participate in cross-functional process activities/initiatives and improvement projects to represent the function; identify resources from the function to support the cross-functional projects, knowledge exchange and sharing lessons learned