Key Responsibilities:
- Design and implement regulatory strategies for precision in-vitro diagnostics and companion diagnostics globally
- Lead submissions for investigational and pre-market in-vitro diagnostics in collaboration with regulatory therapeutics leads
- Ensure integration of in-vitro diagnostics regulatory input into drug development strategies
- Align with country regulatory teams to meet local requirements and deliver timely submissions
- Prepare and coordinate briefing materials and participate in health authority meetings
- Manage responses to health authority requests and oversee follow-up activities
- Support compliance and training initiatives related to in-vitro diagnostics regulations and procedures
Essential Requirements:
- Minimum 4–6 years of experience in the pharmaceutical industry with a focus on IVD/CDx
- Proven track record contributing to regulatory projects involving in vitro diagnostics or companion diagnostics
- Strong understanding of global regulatory pathways including IDE, NDA/BLA, 510(k), and PMA submissions
- Familiarity with assay validation processes and Clinical Laboratory Improvement Amendments (CLIA) standards
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
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility & Accommodation : Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
