Dr. Christina Nicolodi
Skills
Timeline
Professional experience for Christina Nicolodi
- Current 4 years and 11 months, since Mar 2020
Regulatory Affairs Consultant
Nicolodi Regulatory Affairs Consulting Services
- 4 years and 4 months, Jun 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 years and 5 months, May 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 years and 6 months, Dec 2012 - May 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 years and 4 months, Sep 2012 - Dec 2014
Lecturer
IMC Fachhochschule Krems
Lecturer International Regulatory Affairs with Special Focus on Asian Countries
- 5 years and 4 months, Jun 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 years, Jun 2005 - May 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
Educational background for Christina Nicolodi
- 4 years and 1 month, Sep 2010 - Sep 2014
Klinische Pharmakologie
Medizinische Universität Wien
- 5 years and 8 months, Feb 1999 - Sep 2004
Mikrobiologie
Karl Franzens Universität Graz
Languages
German
First language
English
Fluent
Italian
Intermediate
XING – The jobs network
Over 1 million jobs
Find just the right job for you on XING.
Job offers just for you
Get found by employers and over 20,000 recruiters.
22 million members
Connect with new people and gather inspiration to boost your working life.
Free membership
Basic membership is free, but the opportunities are priceless.