Arnaud BIERMANN, MSc, BSc

Senior Regulatory Affairs Manager (Biologic/Drug/Combination Product) at Altamira Therapeutics
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Contact Information
us****@****om
(386) 825-5501
Location
Basel, Basel, Switzerland, CH
Languages
  • English Native or bilingual proficiency
  • German Limited working proficiency
  • Italian Elementary proficiency
  • English Full professional proficiency

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Credentials

  • Networking Evening for Life Sciences Leaders
    Alira Health, Basel (4051), Switzerland
    Jul, 2022
    - Nov, 2024
  • ICH Q12 training
    TOPRA, Geneva (1217), Switzerland
    May, 2021
    - Nov, 2024
  • Lean Manager
    CUBIK Partners, Fribourg (1752), Switzerland
    Aug, 2020
    - Nov, 2024
  • DIA Europe 2020
    DIA, Brussels, Belgium
    Mar, 2020
    - Nov, 2024
  • 9th Semi-Annual EU Medical Device Regulatory Affairs Conference
    Q1 PRODUCTIONS, Brussels, Belgium
    Sep, 2019
    - Nov, 2024
  • Filing Variations
    PTI, London, United Kingdom
    Nov, 2018
    - Nov, 2024
  • Intensive MDR/IVDR Readiness & Transition Management Workshop [SPEAKER]
    Q1 PRODUCTIONS, Brussels, Belgium
    May, 2016
    - Nov, 2024
  • An Introduction to Medical Device Software: Regulations & Requirements
    MANAGEMENT FORUM, London, United Kingdom
    Apr, 2016
    - Nov, 2024
  • Medical Devices registration of export
    ISIFC, Besançon (25), France
    Sep, 2015
    - Nov, 2024
  • Drug/Device and Device/Drug Combinations in the EU and USA: Practical Guidance on Borderline Issues and Combination Products
    MANAGEMENT FORUM, London, United Kingdom
    Apr, 2015
    - Nov, 2024
  • Leadership Workshop
    The BRIDGE, Frankfurt am Main, Germany
    Apr, 2015
    - Nov, 2024
  • CFDA Testing and Regulation of Medical Devices
    NAMSA, Lyon (69), France
    Oct, 2014
    - Nov, 2024
  • Regulatory Requirements & Strategy for IDE & PMA Applications; understanding all aspects of a PMA submission including Quality System & Clinical Trial information
    EMERGO GROUP, Frankfurt am Main, Germany
    Oct, 2014
    - Nov, 2024
  • 3rd Annual European Medical Device & Diagnostic Regulation Conference [SPEAKER & PANELIST]
    Q1 PRODUCTIONS, Brussels, Belgium
    Jun, 2014
    - Nov, 2024
  • Risk Management and Risk Analysis per ISO 14971 revision 2012, and its relation with Essential Requirements of the EU MDD 2007/47
    NAMSA, Geneva (1217), Switzerland
    Oct, 2013
    - Nov, 2024
  • Clinical Evaluation Report & Requirements regarding PMCF for Medical Devices in Europe
    EMERGO GROUP, Geneva (1217), Switzerland
    Sep, 2013
    - Nov, 2024
  • 2nd Annual European Medical Device Regulation Conference
    Q1 PRODUCTIONS, Brussels, Belgium
    Apr, 2013
    - Nov, 2024
  • New Clinical Trial Partnerships in the UK – Chances and Opportunities in the Future
    UK TRADE & INVESTMENT, Geneva (1216), Switzerland
    Nov, 2011
    - Nov, 2024
  • Good Clinical Practices for Clinical Trials
    BARNETT EDUCATIONAL SERVICES, Strasbourg (67), France
    Nov, 2010
    - Nov, 2024
  • Regulatory strategy and non-clinical / clinical drug development: Evaluation and interactions
    Cefira, Paris (92), France
    Nov, 2010
    - Nov, 2024
  • Involvement of the biomarkers in the different stages of the pharmaceutical development
    Cefira, Strasbourg (67), France
    Sep, 2009
    - Nov, 2024
  • Building the eCTD
    PTI, London, United Kingdom
    Oct, 2008
    - Nov, 2024
  • Presentation Skills
    Strasbourg (67), France
    Nov, 2007
    - Nov, 2024
  • Linguistic training in English
    nova performance, Strasbourg (67), France
    Jan, 2008
    - Nov, 2024

Experience

  • Altamira Therapeutics
    • Bermuda
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Senior Regulatory Affairs Manager (Biologic/Drug/Combination Product)
      • Nov 2021 - Present

      HEAD OF GLOBAL REGULATORY AFFAIRS (PHARMACEUTICALS) HEAD OF GLOBAL REGULATORY AFFAIRS (PHARMACEUTICALS)

  • CSL Vifor
    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • (Senior) Regulatory Affairs Manager (Biologic/Drug/OTC/Combination Product/Medical Device)
      • Feb 2018 - Oct 2021

      GLOBAL REGULATORY AFFAIRS | LEAN MANAGER (OPERATIONAL EXCELLENCE) GLOBAL REGULATORY AFFAIRS | LEAN MANAGER (OPERATIONAL EXCELLENCE)

  • Quotient Limited
    • Switzerland
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Senior Regulatory Affairs Officer (Biologic/In Vitro Diagnostic Medical Device)
      • Mar 2017 - May 2017

      GLOBAL REGULATORY AFFAIRS GLOBAL REGULATORY AFFAIRS

  • Merz Therapeutics
    • Germany
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Freelance Senior Regulatory Affairs Consultant (Combination Product/Medical Device)
      • Sep 2016 - Feb 2017

      GLOBAL REGULATORY AFFAIRS GLOBAL REGULATORY AFFAIRS

  • Merz - Anteis SA
    • Switzerland
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Head of Regulatory Affairs Strategy (Combination Product/Medical Device/Cosmetic)
      • Jan 2015 - Aug 2016

      HEAD OF GLOBAL REGULATORY AFFAIRS

    • Senior Regulatory Affairs Manager (Combination Product/Medical Device/Cosmetic)
      • Jul 2013 - Dec 2014

      HEAD OF GLOBAL REGULATORY AFFAIRS

    • Regulatory Affairs Manager (Combination Product/Medical Device/Cosmetic)
      • Jan 2013 - Jul 2013

      HEAD OF GLOBAL REGULATORY AFFAIRS

    • Regulatory Affairs Specialist (Combination Product/Medical Device/Cosmetic)
      • May 2012 - Dec 2012

      GLOBAL REGULATORY AFFAIRS

  • Gedeon Richter - PregLem S.A.
    • Switzerland
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Manager (Drug)
      • Sep 2011 - Mar 2012

      GLOBAL REGULATORY AFFAIRS GLOBAL REGULATORY AFFAIRS

  • IQVIA
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Regulatory Affairs Officer (Biologic/Vaccine/Drug/OTC)
      • Apr 2010 - Sep 2011

      GLOBAL REGULATORY AFFAIRS

    • Regulatory Affairs Associate (Biologic/Vaccine/Drug/OTC)
      • Aug 2007 - Mar 2010

      GLOBAL REGULATORY AFFAIRS

    • Regulatory Affairs Trainee (Biologic/Vaccine/Drug/OTC)
      • Feb 2007 - Aug 2007

      GLOBAL REGULATORY AFFAIRS

  • IQVIA
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Regulatory Affairs Trainee (Biologic/Vaccine/Drug/OTC)
      • Jul 2006 - Aug 2006

      GLOBAL REGULATORY AFFAIRS GLOBAL REGULATORY AFFAIRS

  • IQVIA
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Regulatory Affairs Trainee (Biologic/Vaccine/Drug/OTC)
      • Jun 2005 - Jul 2005

      GLOBAL REGULATORY AFFAIRS GLOBAL REGULATORY AFFAIRS

Education

  • University of Pharmacy (Louis Pasteur University (ULP)) at Illkirch, Strasbourg (67) / France
    Master of Sciences degree (M.Sc.), in Community Law & Pharmaceutical Regulations, with honors
    2005 - 2007
  • University of Chemistry (ULP) at Esplanade, Strasbourg (67) / France
    Bachelor of Sciences degree (B.Sc.), in Chemistry, with honors
    2004 - 2005

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