Manager of Regulatory Affairs for Precision Medicine
3 weeks ago
As a pivotal member of our Development Team, you will contribute to our mission of transforming healthcare to enhance and prolong lives. We are in search of exceptional talent to join our efforts in providing hope to individuals facing health challenges and their families.
Position ResponsibilitiesKey Responsibilities:
- Drive the global regulatory framework and initiatives for precision in vitro diagnostics (IVDs), including companion diagnostics (CDx) across various regions such as the US, EU, Japan, and China, focusing on premarket submissions and regulatory interactions.
- Partner with the Project Management Regulatory Affairs lead to ensure seamless integration of diagnostic regulatory strategies and the execution of regulatory preparedness across multiple functions.
- Provide early regulatory insights for initial development trials and advanced clinical studies to Technical and Clinical Development teams.
- Collaborate closely with the Regulatory Affairs Project Management lead to define strategies and objectives for engagements with regulatory bodies regarding IVD devices.
- Oversee the preparation and submission processes, contributing to the development of comprehensive summary documents and coordinating meetings with regulatory authorities.
- Formulate the most effective strategies for the preparation and submission of diagnostic regulatory dossiers, ensuring thorough review and contribution to global submissions relevant to IVDs and CDx.
Required Experience:
- Proven experience in regulatory affairs within the diagnostics sector, with a strong understanding of molecular diagnostics being advantageous.
- Familiarity with drug development processes and regulatory requirements, particularly in relation to EU IVDR and US LDT.
- Excellent interpersonal skills and experience in navigating complex, cross-functional environments.
- Proficiency in English is essential.
At Novartis, we recognize that addressing health challenges requires more than just innovative science; it demands a collaborative community of dedicated individuals. Together, we strive to inspire and support one another in achieving breakthroughs that significantly impact patients' lives.
Commitment to Diversity & InclusionNovartis is dedicated to fostering an inclusive workplace and building diverse teams that reflect the patients and communities we serve.
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