Dr. Christina Nicolodi
Selbstständig, Regulatory Affairs Consultant, Nicolodi Regulatory Affairs Consulting Services
Laxenburg, Österreich
Werdegang
Berufserfahrung von Christina Nicolodi
Bis heute 4 Jahre und 5 Monate, seit März 2020
Regulatory Affairs Consultant
Nicolodi Regulatory Affairs Consulting Services
4 Jahre und 4 Monate, Juni 2016 - Sep. 2020
Regulatory Affairs
Shire Pharmaceuticals
Evaluating regulatory requirements for the development of recombinant coagulation factors AMD Genetically modified organisms. Preparing and maintaining of regulatory documents for submissions. Organizing and conducting Pre-submission meetings and scientific advices with local CAs and EMA. Organizing, submitting and maintaining of Marketing authorization applications via the centralized procedure. Submission of orphan drug designations
5 Jahre und 5 Monate, Mai 2015 - Sep. 2020
Regulatory Affairs
Baxalta Innovations GmbH
Evaluating regulatory requirements for the development of vaccines and recombinant coagulation factors Preparing and maintaining of regulatory documents for submissions Organizing and conducting Pre-submission meetings and scientific advices with local CAs and EMA Organizing, submitting and maintaining of Marketing authorization applications via the centralized procedure Submission of orphan drug designations
2 Jahre und 6 Monate, Dez. 2012 - Mai 2015
Regulatory Affairs
Baxter Innovations GmbH
Responsibility for biotechnological products for EU, EEA and Middle Eastern countries including preparation and submission of MAAs, variations, renewals Scientific advices with national and international health authorities RA expert for orphan drug products (Applications, maintenance) Preparation and submission of clinical trial applications
2 Jahre und 4 Monate, Sep. 2012 - Dez. 2014
Lecturer
IMC Fachhochschule Krems
Lecturer International Regulatory Affairs with Special Focus on Asian Countries
5 Jahre und 4 Monate, Juni 2007 - Sep. 2012
Regulatory Affairs
AVIR Green Hills Biotechnology
Evaluation of regulatory requirements of influenza vaccines and advanced therapies Preparation and management of scientific advices with national and international health authorities (incl. EMA and FDA) Writing and review of regulatory, clinical, nonclinical and CMC documents Preparation and submission of clinical trial applications Preparation and submission of pharmacovigilance documents following EC NTA Volume 10
2 Jahre, Juni 2005 - Mai 2007
Head Regulatory Affairs & Drug Safety
Grünenthal GesmbH
Preparation and submission of marketing authorisation applications, variations, renewals and withdrawals (MRP, DCP, national) Preparation of documents for the MA dossier (Module 1 - 5) Establishment and handling of a pharmacovigilance system Preparation, organisation and execution of non-interventional clinical trials (NITs) Establishment of a local crisis management system
2003 - 2005
Regulatory Affairs Assistant
Torrex Chiesi
Regulatory Affairs Assistant Preparation and Maintenance of MA dossiers for CEE countries
Ausbildung von Christina Nicolodi
4 Jahre und 1 Monat, Sep. 2010 - Sep. 2014
Klinische Pharmakologie
Medizinische Universität Wien
5 Jahre und 8 Monate, Feb. 1999 - Sep. 2004
Mikrobiologie
Karl Franzens Universität Graz
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Italienisch
Gut