Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
Major Accountabilities:
You will routinely identify and escalate internally, relevant regulatory information (e.g. relevant laws, guidelines etc.) to facilitate decision making to ensure global development is both compliant and quality aligned with Novartis business objectives.
Collect and communicate this intelligence and any insights on Novartis products to Regulatory Affairs Drug Unit, Regions and functions.
Prepare analysis reports and contribute to internal knowledge management systems, coordinating internal feedback from cross functional teams on draft regulations and guidelines.
Communicate new and emerging regulatory requirements to RA colleagues and relevant line functions via oral and written communication e.g. newsletters, information e-mails.
Support internal activities for the development of policy strategies and advocacy plans.
Essential Requirements:
Bachelor's or Master's Degree.
Experience in regulatory affairs, and/or Medicine/Biologics development.
Good knowledge of EU scientific advice/variation processes.
Strong interpersonal, communication and negotiation skills.
Experience of working in a complex, cross functional environment, within either industry or HA setting.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.