Pia Angela Sanzone

European Regulatory Affairs Director @Tempus AI

Milan, IT
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2023 — Present

European Regulatory Affairs Director @Tempus AI

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Milan, IT

EDUCATION

2008 — 2009

Medical Research Council – Human Nutrition Research, Cambridge, U.K.

Master of Science - MS, Nutrition Sciences

2002 — 2006

Università Politecnica delle Marche

Bachelor's degree, Natural Sciences

2006 — 2009

Università Politecnica delle Marche

Master of Science (MSc), Biomethodology

2009 — 2013

University of Southampton

Doctor of Philosophy (PhD), Synthetic Biology

2006 — 2007

Ulster University

Master of Science - MS, Biotechnology Research

SKILLS

Assay DevelopmentWorkbench 2008 Sp1Sequenom MassarrayDna SequencingR&DEquipments ValidationCommunication, Fundraising and Event ManagementDnaIn Vitro Diagnostic (Ivd) DevicesPreparation and Maintenance of Project DocumentsNanostring TechnologiesRecord KeepingIcp-MsQpcrSop PreparationMolecular BiologyPageLaboratory SkillsPcrIso 13485, 34, 35, 9001Problem SolvingBiotechnologyProtein PurificationCe MarkingMolecular CloningMass SpectrometryScienceBiochemistrySmdMicronutrientsCell CultureProtein ExpressionWestern BlottingDroplet Digital PcrLife SciencesProject ManagementGlpLaboratoryTransfectionMolecular Diagnostics

ABOUT PIA ANGELA SANZONE

I’m passionate about advancing diagnostics and precision medicine, bringing 10+ years of experience across regulatory strategy, clinical trial enablement, and molecular diagnostics development in Europe and the UK. I lead regulatory strategies for diagnostic device approvals under IVDR and CTR, working closely with notified bodies, NCAs, ECs, and EU regulatory authorities to bring innovative diagnostics safely to patients.I enjoy enabling molecular diagnostics in pharma clinical trials and contributing to global diagnostic standards, including initiatives for the WHO. With hands-on EU–US regulatory experience, I bridge regulatory expectations across continents, aligning strategies and helping teams navigate complex frameworks to accelerate innovation.I thrive at the intersection of regulatory, clinical, and commercial objectives, turning challenges into solutions that advance precision medicine.

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Pia Angela Sanzone — European Regulatory Affairs Director at Tempus AI in Milan, IT | Unifers