Dr. Christina Nicolodi

Selbstständig, Regulatory Affairs Consultant, Nicolodi Regulatory Affairs Consulting Services

Laxenburg, Austria

Skills

Strategic RA planning
Clinical trial applications
Marketing authorization applications
Centralised Procedures
Scientific advices
Scientific writing
Biological and biotechnological products
Orphan drug products
Genetically modified organisms
ATMPs
Gene Therapy
Vaccines

Timeline

Professional experience for Christina Nicolodi

  • Current 4 years, 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

Interests

Sport
Musik
Oper
Klassische Musik
Klassischer Gesang
Lesen
Personal Coaching

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