Global Program Regulatory Manager/Sr (Ophthalmology)
Location: East Hanover, New Jersey
Internal Number: 327164BR
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.
Your responsibilities include, but are limited to: * 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 * Lead or coordinate Health Authority meetings in assigned region(s) * Contribute to the development of global and local labelling and review of promotional and non-promotional material 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