Global Program Regulatory Director (Life Cycle Management)
Location: East Hanover, New Jersey
Internal Number: 324142BR
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 Life Cycle Management (LCM) 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: * Lead and supervise assigned regulatory liaisons (8-10 direct reports) across three GDD sites (Basel/East Hanover/Hyderabad) responsible for regulatory life cycle of marketed products within the assigned Therapeutic Area * Provide regulatory direction to assigned LCM portfolio * Ensure high quality and globally aligned regulatory documents to achieve optimal life cycle management submission * Leverage regional expertise and ensure that Regional/CPO input is sought and incorporated into global regulatory LCM strategy * Ensure appropriate TA input and consistency of HA interactions and registration activities within and across TAs in line with global strategy * Ensure high quality and professional interactions with HAs globally including participation in key formal and informal HA contacts as required. * Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall LCM plan and develop mitigation/contingency plans for identified risks