Dr. Fabiana Geller
Angestellt, Wissenschaftlicher Mitarbeiter Regulatory Affairs, Retterspitz GmbH & Co. KG
Munich, Deutschland
Werdegang
Berufserfahrung von Fabiana Geller
Bis heute 1 Jahr und 4 Monate, seit März 2023
Wissenschaftlicher Mitarbeiter Regulatory Affairs
Retterspitz GmbH & Co. KG
* Planung und Umsetzung von Zulassungsprojekten bei europäischen Behörden * Erstellung und Bearbeitung von Zulassungsdossiers für Arzneimittel * Bearbeitung und Einreichung von Änderungsanzeigen * Erstellung und Pflege von Produktinformationstexten und Artwork-Management
* Creation and submission of national change notifications/extension applications * Technical and content check of the artwork * Processing of Module 3 documents * Maintenance of approval databases * Correspondence with authorities
1 Jahr und 7 Monate, März 2019 - Sep. 2020
Drug Regulatory Affairs Pharmacist
Denk Pharma GmbH & Co. KG* New registrations and renewals of pharmaceuticals and food supplements for the regions Central America, Africa, Western Asia/ Eastern Europe, and Arabia * Organization and submission of the necessary regulatory documents to authorities * Implementation of change notifications * Maintenance of the document management system and databases
4 Monate, Nov. 2018 - Feb. 2019
Project Applications in Clinical Research
TimePartner Personalmanagement GmbH
* GlaxoSmithKline GmbH & Co. KG via TimePartner Personalmanagement GmbH, Munich * Creation and organization of administrative documents * Document management in the area of clinical research * Quality control and assurance of metadata and documents * Correct assignment of documents to the respective category * Transfer of all relevant documents into a database * Close collaboration with the study team “Development and Research”
2 Monate, Mai 2018 - Juni 2018
Pharmacist
Inosolve Group
* Technical assistance, validation, qualification and calibration at Sandoz (Kundl/Schachtenau) * Review of legal and corporate requirements * Organization of administrative documents
1 Jahr und 4 Monate, Jan. 2017 - Apr. 2018
Parental leave
-
1 Jahr und 8 Monate, Feb. 2016 - Sep. 2017
Pharmacist
Brazilian Army
* Management of hospital, odontological and pharmacological materials to all military organizations in the military region * Managing budget and staff * Creation and maintenance of document management systems and databases
6 Monate, Juli 2015 - Dez. 2015
Lecturer
SENAC
Lectures on biophysics and systemic pathology
4 Jahre und 1 Monat, Mai 2011 - Mai 2015
Research Assistant
Federal University of Santa Catarina
Standardization and implementation of cell cultures (e.g. scratch and invasion assay) for studies of cell migration and proliferation in pathological processes for the research of new anti-inflammatory, wound healing and anti-tumor agents.
2 Jahre, Aug. 2012 - Juli 2014
Junior Professor
Universidade Federal de Santa Catarina
* Lectures on pharmacognosy, phytochemistry and medicinal chemistry (including clinical research, drug approval, GMP, quality assurance) * Advisor of bachelor's and master's theses in the fields of pharmacognosy, phytochemistry and medicinal chemistry
4 Jahre und 7 Monate, Apr. 2006 - Okt. 2010
Research Assistant
University of Tübingen
* Cooperation network between German and Brazilian universities to study Brazilian medicinal plants * Isolation and structure elucidation of active compounds using analytical methods (e.g. HPLC, LC-MS and NMR spectrometry) as well as biological analysis (e.g. scratch, p38, LOX and COX)
Ausbildung von Fabiana Geller
3 Jahre und 11 Monate, Jan. 2007 - Nov. 2010
Pharmacy
University of Tübingen
Pharmaceutical and Medicinal Chemistry. Eberhard Karls Universität Tübingen, Germany. Isolation, Structure Elucidation and Biological Investigation of Active Compounds in Cordia americana and Brugmansia suaveolens.
3 Jahre und 10 Monate, März 2002 - Dez. 2005
Pharmacy
Universidade de Santa Cruz do Sul
Epidemiological Evolution Study of Bacterial Resistance in Clinical Isolates of Escherichia coli and Staphylococcus aureus from Patients in Hospital
Sprachen
Portugiesisch
Muttersprache
Deutsch
Fließend
Englisch
Gut
Spanisch
Grundlagen