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Caroline Bianchi Strømme is a seasoned expert in regulatory affairs, with a strong background in pharmaceuticals and biotechnology. She holds a PhD in Biochemistry and Molecular Biology from the University of Copenhagen and has worked with prominent companies like Novo Nordisk and Bioteknologirådet. She is fluent in multiple languages, including English, Norwegian, Italian, and Danish.

Experience

  • BIOTEKNOLOGIRÅDET
    • Bergen, Hordaland, Norway
    • Senior advisor
      • Apr 2020 - Present
      • Bergen, Hordaland, Norway

    • Denmark
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Regulatory Affairs Professional, RA Advanced Therapy Medicinal Products (ATMP)
      • Dec 2019 - Apr 2020

      RA Advanced Therapy Medicinal Products is a newly formed department focusing on the development of therapies using new and innovative modalities such as RNA interference and genome editing. During the time I was part of this team, I gained valuable insight into what are the global requirements for the development and approval of advanced medicinal products, with particular focus on US and EU legislation.

    • Regulatory Affairs Clinical Professional, RA Biopharm
      • Sep 2018 - Nov 2019

      haemofilia - regulatory strategy - development projects - clinical trial applications - due diligence -

    • Regulatory Affairs Graduate
      • Sep 2016 - Aug 2018

      During the two-year Regulatory Affairs (RA) graduate program, I have been exposed to various parts of the RA organization in Novo Nordisk, gaining hands-on experience in areas ranging from life cycle management to early drug development. Sept. 2016 - April 2017 RA Clinical – Modern & Human Insulins (HQ, DK)• Insight and experience with Life Cycle Management Activities and the insulin portfolio • Supported label update for the human insulins• Driving and preparing strategic RA documentation for the human insulins May 2017 - Dec 2017 Regulatory Affairs - Latin America (Regional Office, Sao Paulo, Brazil)• Insight and experience with the regulatory environment in Latin America• Driving and conducting strategic projects in Region LATAM, in collaboration with affiliates, International Operations (IO) and HQ. Jan 2018 - Aug 2018 RA Clinical – Obesity Projects (HQ, DK)• Supporting three early development projects within the Obesity therapeutic area• Experience with RA tasks within early drug development, including non-clinical and clinical development

    • Denmark
    • Biotechnology Research
    • 100 - 200 Employee
    • PhD student - Molecular Mechanisms of Disease
      • Jun 2013 - Aug 2016

      During my PhD, I have been working on Epigenetics, answering fundamental questions on how cellular identity is maintained in human cells. This work has been published (Nature Struct. Mol. Biol., 22, 618-626, July 2015), with me as co-shared first author. The paper was highlighted in Nature Struct. Mol. Biol. news and as the editor’s choice in Science (Vol 349, Issue 6250, August 2015).

    • Research Assistant
      • Oct 2012 - May 2013

Education

  • 2013 - 2016
    Københavns Universitet
    Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology
  • 2010 - 2012
    Københavns Universitet
    Master's Degree, Molecular Biomedicine
  • 2007 - 2010
    Københavns Universitet
    Bachelor's Degree, Molecular Biomedicine
  • 2005 - 2007
    St George's British International School, Rome
    High School, International Baccalaureate (IB)

Suggested Services

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Industry Focus. “Government Administration”

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