Maddalena Lazzarin

Regulatory Affairs @Fidia Pharma

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

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WORK HISTORY

Sep 2019 — Present

Regulatory Affairs @Fidia Pharma

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Padua, IT

Submission and maintenance of medical devices CE Certifications: technical file writing, submission to Notified Bodies and deficiencies answers• Partecipation to Notified Bodies audits• Labelling and artworks control and approval• Promotional materials control, approval and submission to Health Authorities• Contact with local partners and distributors (EU and Extra-EU): management of national regulatory requirements (medical devices, drugs and food supplements)

SKILLS

Clinical TrialsElisaFretMolecular BiologyBiochemistrySite-Directed MutagenesisCell Based AssaysPharmacovigilanceBiotechnologyProtein PurificationStem CellsRegulatory AffairsProtein ExpressionPcrMolecular CloningSds-PageFacs AnalysisNmr SpectroscopyMouse ModelsPcr Primer DesignDna LigationWestern BlottingPathogensCell CultureBioinformaticsX-Ray CrystallographyGenome AnalysisDna Extraction

ABOUT MADDALENA LAZZARIN

I have performed my PhD at Novartis Vaccines, having the possibility to receive a highly…

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Maddalena Lazzarin — Regulatory Affairs at Fidia Pharma in Padua, IT | Unifers