Justyna Malinowska
Angestellt, Junior expert, Office for registration of medicinal products, medical devices and biocides
Warszawa, Polen
Werdegang
Berufserfahrung von Justyna Malinowska
Bis heute 14 Jahre und 11 Monate, seit Aug. 2009
Junior expert
Office for registration of medicinal products, medical devices and biocides
* RESPONSIBLE FOR module 3 (CTD) assessment in the Unit for Documentation Assessment of Herbal, Homeopathic and Galenical Medicinal Products ** MAIN TASKS INCLUDE: assessment, in accordance with current EU quality requirements for medicines, of pharmaceutical/quality data provided in applications for a marketing authorisation or applications for a variation to an existing marketing authorisation *** MY WORK INVOLVES: preparation of assessment reports, correspondence with applicants
5 Monate, März 2009 - Juli 2009
Trainee
European Commission / DG SANCO
* TRAINEE PLACEMENT within the team for food contact materials
3 Jahre und 6 Monate, Sep. 2005 - Feb. 2009
Specialist
Office for registration of medicinal products, medical devices and biocides
* RESPONSIBLE FOR coordination of variations to marketing authorisations in the Unit for Variations to Herbal, Homeopathic and Galenical Medicinal Products ** MAIN TASKS INCLUDED: validation of submitted documentation in compliance with current national legislation, interactions with internal/external experts, applicants, other national authorities, preparation of official regulatory documents in the end of the process *** OTHER TASKS also included assessment of module 3 (CTD)
6 Monate, Juli 2003 - Dez. 2003
Trainee
Novartis Pharma AG
STUDENT TRAINING in ‘Chemical and Analytical Development/Analytical R&D’ Department: LC-MS analysis in the determination of impurities in drug substances
1 Monat, Aug. 2002 - Aug. 2002
Trainee
Warsaw Pharmaceutical Company “Polfa”
STUDENT TRAINING: quality control of medicines and pharmaceutical production process under GMP
Ausbildung von Justyna Malinowska
10 Monate, Okt. 2004 - Juli 2005
Chemistry
Université de Bourgogne
MAIN SUBJECTS STUDIED: organometallic chemistry and catalysis, selective organic chemistry, macrocycles, nanomaterials, spectroscopy, electrochemistry
6 Monate, Feb. 2001 - Juli 2001
Polymer Science
Edinburgh Napier University
MAIN SUBJECTS STUDIED: polymer processes, manufacturing with polymers, research project on properties of phosphorescent pigment in polymer matrices
6 Jahre, Okt. 1998 - Sep. 2004
Chemistry/Polymer chemistry
Warsaw University of Technology
MAIN SUBJECTS STUDIED: inorganic chemistry, organic chemistry, physical chemistry, analytical chemistry, specialisation: polymer chemistry, polymer technology, polymer physical chemistry
Sprachen
Französisch
Gut
Polnisch
Muttersprache
Englisch
Fließend