Dr. Johannes Regenbogen

Angestellt, Ass. Director Quality, Takeda Pharmaceuticals International AG
Wien, Austria

Fähigkeiten und Kenntnisse

Produktentwicklung
Medizinprodukte
Bio-Pharmazeutika
Product Development
Medical Device
Biopharmaceuticals
Biologics
Functional Leadership
Cross-functional Leadership
Leadership
R&D
Research and Development
Design Control
ISO 13485
FDA 21 CFR 820
ISO 10993
Medical Device Directive
GMP
GxP
Quality Management Systems
Design Verification
Design Validation
People Management
Teamleitung
Team Building
Teamentwicklung
Due Diligence
Innovationsmanagement
Extramural Funding
Fundraising
Start-up
Hemostasis
Tissue Sealing
Tissue Regeneration
Soft Tissue Repair
Wound Healing
MD Industry
Projektmanagement
PMA
CE mark
510(k)
Life Sciences
Medizinprodukteentwickler
Genomics
Genomik
Business acumen
Biosurgery

Werdegang

Berufserfahrung von Johannes Regenbogen

  • Current 6 years and 2 months, since Apr 2020

    Ass. Director Quality

    Takeda Pharmaceuticals International AG
  • Current 7 years and 7 months, since Nov 2018

    VP Product Development

    CoMotion Drug Delivery Systems

    CoMotion Drug Delivery Systems entwickelt Biopharmazeutika für chirurgische Anwendungen. I am responsible for delivering comprehensive product development plans for the development of combination products in compliance with international regulations, and bring the company to the next level of maturity.

  • 3 years and 9 months, Dec 2014 - Aug 2018

    Director R&D - Principal Scientist - R&D Business Unit Site Lead

    Baxter International

    R&D site lead until August 2018. Driving Innovation & New Product Development of medical devices in the area of hemostats, tissue sealants for surgical applications. Supporting new product initiatives from inception through development, ultimately delivering new products in accordance with the strategic plan and company mission. Managing multi-disciplinary and international multi-site teams while providing functional leadership. People management of up to 8 people. Reporting into senior director R&D.

  • 6 years and 6 months, Nov 2007 - Apr 2014

    Senior Manager R&D

    Baxter Innovation GmbH

    Medical Devices: Technical lead for HEMOPATCH Sealing Hemostat, CE mark 2013, and CELSTAT Hemostatic Dressing 510(k) 2010. Biologics: R&D Lead and Core Team Member. Successfully elevated three pipeline products through pre-clinical to clinical phase II Due Diligence: Authored about 150 technical assessments & due diligences per year in the the market spaces of hemostasis, tissue sealing, regenerative medicine, wound healing, pain management and adjacent fields.

  • 3 months, Aug 2007 - Oct 2007

    Senior Director R&D - Function Head

    Eurofins GATC Biotech GmbH

    R&D function head tasked with portfolio expansion, strategic partnering, and acquisition of extramural funding Heading all R&D activities in the fields of Genome Analysis and Molecular Diagnostics. Member of the Extended Board. Direct report to the board of directors.

  • 4 years and 4 months, Apr 2003 - Jul 2007

    Director R&D - Function Head

    Eurofins GATC Biotech GmbH

    R&D function head tasked with portfolio expansion, strategic partnering, and acquisition of extramural funding Heading all R&D activities in the fields of Genome Analysis and Molecular Diagnostics. Member of the Extended Board. Direct report to the board of directors.

  • 5 years and 5 months, Nov 1997 - Mar 2003

    Co-founder / Manager R&D / Director R&D

    Switch Biotech AG

    Founding Member and Director R&D Reporting to the Board of Directors. Setup of a comprehensive technology platform to support drug development for skin disorders, e.g. Cutaneous Ulcers, Atopic Dermatitis and Psoriasis. Identification of molecular key targets involved in dermatological diseases, subjected to further patenting, product development and licensing activities of the company. People management of up to 7 direct reports.

Ausbildung von Johannes Regenbogen

  • Biochemistry and Molecular Biology

    Ludwig-Maximilian-University, Munich, Germany

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • French

    A1-A2 (Grundkenntnisse)

  • Japanese

    A1-A2 (Grundkenntnisse)

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