Clelia Bonadei
Bis 2018, Medical Devices-Regulatory Affairs Manager, Merz Pharma GmbH & Co. KGaA
Rhein-Main Gebiet, Deutschland
Werdegang
Berufserfahrung von Clelia Bonadei
Bis heute 5 Jahre und 8 Monate, seit Nov. 2018
Regulatory Affairs- Senior Manager, Translational Medicine and Devices
on request
6 Monate, Apr. 2018 - Sep. 2018
Manager for Medical Devices
AESGP
2 Jahre und 3 Monate, Jan. 2016 - März 2018
Medical Devices-Regulatory Affairs Manager
Merz Pharma GmbH & Co. KGaA
Regulatory Affairs Manager-Class I-III medical devices
Regulatory Manager for registration/marketing authorizations of Medical Devices (Class I and IIa) worldwde, with exception of U.S.
5 Jahre, Sep. 2008 - Aug. 2013
Regulatory Intelligence Manager
Merck Serono
I ensure that relevant information from ICH Authorities is provided to the Regulatory Affairs department and to other R&D functions(Pharmacovigilance, Clinical Research, Technical Operations/Manufacturing) worldwide according to their needs. I provide a monthly presentation with a summary of the relevant guidelines/communications from Authorities in team meetings. I compile and distribute a monthly regulatory newsletter and a quarterly CMC newsletter. I am Manager of two internal databases
1 Jahr, Sep. 2007 - Aug. 2008
Regulatory Associate (Clinical Trial Applications)
Parexel International GmbH
Regulatory Lead (International Clinical Trials)
1 Jahr, Sep. 2006 - Aug. 2007
Development Regulatory Affairs-Specialist
Astellas Pharma GmbH München
10 Monate, Nov. 2005 - Aug. 2006
formulation scientist
Sanofi-Aventis Frankfurt am Main
1 Jahr, Aug. 2004 - Juli 2005
internship-pharmaceutical technology
Degussa-Röhm Darmstadt
Ausbildung von Clelia Bonadei
4 Monate, Okt. 2011 - Jan. 2012
Medical Devices
RAPS Online University
2 Jahre und 11 Monate, Sep. 2010 - Juli 2013
Drug Regulatory Affairs
Rheinische Friedrich-Wilhelms-Universität Bonn
interdisciplinary course covering areas of pharmaceutical sciences, law and medicine. Further details are available at the link below: http://www.dgra.de/english/course/study_aim.php
2004 - 2004
Pharmacist
University of Pavia
- Bis heute
Pharmaceutical Sciences
Universita´di Pavia,
Pharmaceutical Technology, Pharmaceutical Chemistry, Pharmacology.
Sprachen
Deutsch
Gut
Englisch
Fließend
Spanisch
Grundlagen
Französisch
Fließend
Italienisch
Muttersprache
Portugiesisch
Grundlagen