Summary
About the Role
Major accountabilities:
Supports the global regulatory strategy and program for precision IVDs including CDx (e.g. US, EU, Japan, China), for premarket submissions, diagnostic partnering, FDA interface, regulatory policy, and practice.
Collaboration with the Project Management RA lead to facilitate integration of Dx regulatory strategy (aligned with drug/diagnostic co-development) and the coordination and implementation of regulatory readiness with other line functions within Project Management and drug RA.
Ensures early diagnostic regulatory input for early development trials and late- stage clinical development to Technical and Clinical Development teams for precision diagnostics. Providing tactical support for the vision of PM RA and the action roadmap for activities with the regulatory bodies, to ensure Novartis’ interests are reflected.
Works directly with RA PM lead in establishing strategy and objectives for meetings with FDA CDRH and other Health Authorities (HA) for IVD devices.
Facilitates the preparation, filing, and contributes to the preparation of summary documents, including coordination and planning for pre-Submission or other meetings with HAs. Develops, manages, and implements plans for timely response to HA requests and coordinates of any applicable follow-up activities.
Develop the most efficient approach to preparation and submission of Dx regulatory dossiers, reviewing and contributing to global dossier on topics relevant to IVDs/CDx. Responsible for facilitating timely submission and approval of Dx submissions under the guidance of the RA PM lead and/or drug RA.
Your Experience:
Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Experience in invitro diagnostics. medical devices or life sciences.
Experience in diagnostics regulatory affairs ideal, with knowledge of molecular diagnostics a plus.
Knowledge of drug development and regulatory affairs requirements, and familiarity with regulatory issues (EU IVDR, US LDT), challenges associated with Drug/ Diagnostic co-development, and Companion Diagnostics
Strong interpersonal skills and experience working in a complex, cross functional organization.
Fluency in English.
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.
