Marco Guerrini
R.A.Manager Coagulation & Critical Care - PMF Lead at Kedrion Biopharma- Claim this Profile
Contact Information
us****@****om
(386) 825-5501
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Location
Lucca, Tuscany, Italy, IT
Languages
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Italiano Native or bilingual proficiency
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Inglese Professional working proficiency
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Experience
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Kedrion Biopharma
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Pharmaceutical Manufacturing
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700 & Above Employee
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R.A.Manager Coagulation & Critical Care - PMF Lead
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Nov 2020 - Present
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Regulatory Affairs Specialist - PMF Lead
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Feb 2019 - Nov 2020
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Specialista di prodotto
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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
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Regulatory Affairs Analyst
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2011 - Nov 2020
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Education
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Università di Pisa
Corso di Master Universitario di 2° livello-CMU2 in Attività regolatorie: medicinali, prodotti de..., Farmacia -
Università di Pisa
Specialist Degree in Pharmacy, Farmacia
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