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.
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) 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 early projects with little or no RA sub-team support as appropriate. This role supports the Malaria portfolio & US/LACN activities for the Ophthalmology Established products.
Your Responsibilities include, but are not limited to: * Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans. * Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of key program changes/information to support appropriate, timely communication to Health Authorities globally. * Lead interactions with regulatory consultants/advisors for strategic input and challenge. * Develop global regulatory strategy and plans for Health Authority (HA) interactions as appropriate. * Contribute to and review HA responses, as required, to ensure appropriate, consistent and complete answers to any HA questions. Ensure responses are in line with development strategy. * May lead interaction with HAs during key HA meetings * Proactively address issues, gaps, options and trade-offs for the development plan to increase the probability of an optimal and timely submission and approval