Summary
About the Role
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.
Your experience:
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: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?: https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
