Rainer Wolber
Angestellt, Director Innovation & Regulatory Affairs, Schülke & Mayr GmbH
Hamburg, Deutschland
Über mich
TECHNOLOGY STRATEGY AND CROSS-DISCIPLINARY THINKING - outstanding solutions through passionate fusion of different disciplines in science & technology with customer & patient needs LEAD TEAMS TO OUTSTANDING RESULTS: with agile mindset and new perspectives based on years of leadership experience of cross-functional and international teams BROAD EXPERTISE IN RESEARCH & DEVELOPMENT - in-depth understanding of research and prototyping as well as operational product development CLINICAL STRATEGY – superior claim proofs and benefits by smart clinical approaches EXPLOIT REGULATORY & CLINICAL DIVERSITY - pragmatically use strengths of various regulatory classes: medical devices, pharmaceuticals, biocides and cosmetics SKIN BIOLOGY & ACTIVE INGREDIENT IDENTIFICATION: efficacy proof by in vivo, ex vivo, in vitro and in silico technologies OPEN INNOVATION & NETWORKING - develop sustainable relationships between and within academia and industry
Werdegang
Berufserfahrung von Rainer Wolber
Bis heute 1 Jahr und 4 Monate, seit März 2023
Director Innovation & Regulatory Affairs
Schülke & Mayr GmbH
• Research & Development • Medical & Clinical Science • Strategic Innovation & Project Management R&D • Regulatory Affairs & Chemical Compliance
1 Jahr und 10 Monate, Mai 2021 - Feb. 2023
Director Clinical Affairs & Health Economics
Drägerwerk AG & Co. KGaA• clinical strategy & documentation for Dräger products – Medical Division • health economics
1 Jahr und 3 Monate, Jan. 2020 - März 2021
Director R&D / Medical & Clinical Affairs Health Care - Beiersdorf
Beiersdorf AG• technological and clinical strategy Hansaplast / Elastoplast / ABC / Guttaplast • Medical Device Regulation (MDR) implementation board
3 Jahre, Jan. 2017 - Dez. 2019
Director Innovation & Compliance Health Care, Business Unit Health Care
Beiersdorf AG• founding member of business unit ‘Health Care’ • strategy development (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
• pipeline and product portfolio responsibility ‘Hansaplast/Elastoplast’ (medical devices, pharmaceuticals, cosmetics, biocides, personal protection equipment (PPE) • technology and patent strategy
• 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
5 Jahre und 1 Monat, Dez. 2007 - Dez. 2012
Group Manager Prototyping & Product Dev. Health Care
Beiersdorf AG• 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
• 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
• 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
• 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
1 Jahr und 3 Monate, Mai 1997 - Juli 1998
Research Scientist (laboratory of microbiology)
Beiersdorf AG• 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
Ausbildung von Rainer Wolber
3 Jahre, Jan. 1994 - Dez. 1996
Humanbiologie
Philipps-Universität Marburg
• Thema der Dissertation: „Einfluss von oxidativem Stress auf die menschliche Haut unter besonderer Berücksichtigung des Atopischen Ekzems“ • Schwerpunkte: Biochemie / Molekularbiologie / Zellbiologie
7 Monate, Okt. 1990 - Apr. 1991
Humanmedizin
Philipps-Universität Marburg
5 Jahre und 4 Monate, Okt. 1988 - Jan. 1994
Humanbiologie
Philipps-Universität Marburg
• Thema der Diplomarbeit „Endogene Schutzmechanismen der Haut gegen UV-Strahlung“ • Schwerpunkte: Biochemie / Molekularbiologie / Zellbiologie
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
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