Marco Guerrini

R.A.Manager Coagulation & Critical Care - PMF Lead at Kedrion Biopharma
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Contact Information
us****@****om
(386) 825-5501
Location
Lucca, Tuscany, Italy, IT
Languages
  • Italiano Native or bilingual proficiency
  • Inglese Professional working proficiency

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Experience

    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • R.A.Manager Coagulation & Critical Care - PMF Lead
      • Nov 2020 - Present

    • Regulatory Affairs Specialist - PMF Lead
      • Feb 2019 - Nov 2020

    • Specialista di prodotto
      • 2011 - Nov 2020

      • Management of Kedrion S.p.A Plasma Master File (PMF) - evaluation of changes, update of the documentation (eCTD) and submission to EMA (European Medicines Agency).• Contacts with european (EMA) and national (italian ISS) Authorities - emails, teleconferences.• Member of the PMF Task force at PPTA (Plasma Protein Therapeutics Association) for Kedrion• Contacs with clients - contact point for requests and PMF documentation distribution• Management of PMF internal meetings - scheduling, coordination.• Training on PMF Show less

    • Regulatory Affairs Analyst
      • 2011 - Nov 2020

Education

  • Università di Pisa
    Corso di Master Universitario di 2° livello-CMU2 in Attività regolatorie: medicinali, prodotti de..., Farmacia
    2009 - 2010
  • Università di Pisa
    Specialist Degree in Pharmacy, Farmacia

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