Rainer Wolber, PhD

Director Innovation & Regulatory Affairs at Schülke & Mayr
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Location
Stadt Hamburg, Hamburg, Germany, DE

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Experience

    • Germany
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Director Innovation & Regulatory Affairs
      • Mar 2023 - Present

      • Research & Development • Medical & Clinical Science • Strategic Innovation & Project Management R&D • Regulatory Affairs & Chemical Compliance • Research & Development • Medical & Clinical Science • Strategic Innovation & Project Management R&D • Regulatory Affairs & Chemical Compliance

    • Germany
    • Manufacturing
    • 700 & Above Employee
    • Director Clinical Affairs & Health Economics
      • May 2021 - Feb 2023

      • clinical strategy & documentation for Dräger products – Medical Division • health economics • clinical strategy & documentation for Dräger products – Medical Division • health economics

    • Germany
    • Personal Care Product Manufacturing
    • 700 & Above Employee
    • Director R&D / Medical & Clinical Affairs Health Care
      • Jan 2020 - Mar 2021

      • technological and clinical strategy Hansaplast / Elastoplast / ABC / Guttaplast• Medical Device Regulation (MDR) implementation board

    • Director Innovation & Compliance Health Care
      • Jan 2017 - Dec 2019

      • founding member of business unit ‘Health Care’• strategy development (responsible for research and development incl. packaging development, medical & clinical affairs as well as regulatory affairs for all ‘Health Care’ products (Hansaplast / Elastoplast / ABC / Guttaplast), incl. postmarket surveillance)• intermediary to competent authorities, notified bodies and external cooperation partners

    • Head of R&D Health Care
      • Jan 2015 - Dec 2016

      • pipeline and product portfolio responsibility ‘Hansaplast/Elastoplast’ (medical devices, pharmaceuticals, cosmetics, biocides, personal protection equipment (PPE)• technology and patent strategy

    • Head of R&D Eucerin
      • Jan 2013 - Dec 2014

      • pipeline and product portfolio responsibility Eucerin (dermo cosmetics with diverse technologies: emulsions, surfactant systems, aerosols, UV filters, active ingredients)• intermediary to international marketing and medical management Eucerin as well as academia / KOLs and external cooperation partners

    • Group Manager Prototyping & Product Deveopment Health Care
      • Dec 2007 - Dec 2012

      • pipeline and product portfolio responsibility ‘Hansaplast/Elstoplast’ (medical devices, pharmaceuticals, cosmetics, biocides, personal protection equipment (PPE)• steering cooperation with universities, scientific institutions, key opinion leaders (KOLs) and industrial partners• steering of clinical trials, complex volunteer studies and in vitro examinations, mainly for medical devices and cosmetics

    • Manager Research Photobiology - Sun Care
      • Nov 2004 - Nov 2007

      • research of skin pigmentation physiology and skin interaction with topical sun care products (focus: skin pigmentation)• steering international research cooperation (diverse universities, NIH (Bethesda, USA), DKFZ)• member of COLIPA Task Force ‘In vitro Protection Methods - Sun Care’, Brussels, Belgium• assay development for in vivo, ex vivo and in vitro studies (focus: own organotypical 3D skin models)• in silico assay development

    • Manager Research Photobiology
      • Mar 1999 - Oct 2004

      • research on physiology of skin´s own protection mechanism and its interaction with topical sun care products (focus: antiinflammatory systems, antioxidants) • screening assay development (in vitro / primary cell cultures) incl. high-throughput screening (HTS)• development of non-invasive biophysical methods for efficacy proof topically applied products

    • Manager Research Skin Protection / Derma
      • Aug 1998 - Feb 1999

      • researching healthy and damaged skin physiology using in vitro / ex vivo and in vivo methods (biochemical / cell biological / biophysical)• executing volunteer studies (in vivo) with non-invasive, biophysical techniques for efficacy proof of (dermo-) cosmetic products

    • Research Scientist (laboratory of microbiology)
      • May 1997 - Jul 1998

      • researching the interaction of microorganisms (permanent skin flora and pathogenic germs) with human skin as well as the necessary assay development (in vitro / ex vivo / in vivo)• identification of active ingredients to influence skin´s microflora

Education

  • Philipps-Universität Marburg
    Doctor of Philosophy - PhD, Biochemistry & Cell Biology
    1993 - 1997
  • Philipps-Universität Marburg
    human biologist, diploma, biochemistry, molecular biology, cell biology
    1988 - 1993

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