Dr. Fabiana Geller

Pharmacist with experience in regulatory affair field

Angestellt, Wissenschaftlicher Mitarbeiter Regulatory Affairs, Retterspitz GmbH & Co. KG

Munich, Deutschland

Fähigkeiten und Kenntnisse

Regulatory Affairs
Quality Assurance
Strategic thinking
Management
Pharmaceuticals
Research
Pharmacy
Clinical Research
Relationship building
Problem Solving
Communication Skills
Team work
Leadership

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

  • 2 Jahre und 1 Monat, Dez. 2020 - Dez. 2022

    Regulatory Affairs Specialist

    PUREN Pharma GmbH & Co. KG

    * 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

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