Svenja Hutzler

Regulatory Affairs at regenold GmbH
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Contact Information
us****@****om
(386) 825-5501
Location
Freiburg, Baden-Württemberg, Germany, DE
Languages
  • Deutsch Native or bilingual proficiency
  • Portugiesisch Limited working proficiency
  • Englisch Professional working proficiency
  • Spanisch Elementary proficiency
Skills

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Credentials

  • Cambridge Certificate: Certificate in Advanced English (CAE/C1)
    -
    Apr, 2014
    - Nov, 2024

Experience

  • regenold GmbH
    • Germany
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs
      • May 2018 - Present

  • regenold GmbH
    • Germany
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Trainee
      • Dec 2016 - May 2017

  • Novartis
    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Drug Regulatory Affairs (DRA) Graduate, RegCMC
      • Jun 2016 - Nov 2016

  • Roche
    • Switzerland
    • Biotechnology Research
    • 700 & Above Employee
    • Internship, Pharma Technical Regulatory
      • Oct 2015 - Apr 2016

      Department of Pharma Technical regulatory (PTR)- Biologics• Maintenance of regulatory documentation in Module 3 of CTD• Preparation of regulatory documentation for authority inspections• Interaction with the international platforms of PTR• Compliance Checks• Organizing of regular site meetings of PTR including the preparation of meeting (agenda and minutes)• Support of local change control Department of Pharma Technical regulatory (PTR)- Biologics• Maintenance of regulatory documentation in Module 3 of CTD• Preparation of regulatory documentation for authority inspections• Interaction with the international platforms of PTR• Compliance Checks• Organizing of regular site meetings of PTR including the preparation of meeting (agenda and minutes)• Support of local change control

  • BASF
    • Germany
    • Chemical Manufacturing
    • 700 & Above Employee
    • Internship, Analytics (GMP)
      • Mar 2012 - Mar 2012

      Department of the Crop Protection division at BASF• Conducting chemical analyses with a special focus on chromatography (HPLC)• Becoming acquainted with laboratory processes - Analysis assignments• Working in formulation development Department of the Crop Protection division at BASF• Conducting chemical analyses with a special focus on chromatography (HPLC)• Becoming acquainted with laboratory processes - Analysis assignments• Working in formulation development

Education

  • Albert-Ludwigs-Universität Freiburg im Breisgau
    Master of Science (M.Sc.), Pharmazeutische Wissenschaften
    2014 - 2017
  • European Centre for Regulatory Affairs (EUCRAF)
    Regulatory Affairs for Biopharmaceuticals including ATMPs
    2014 - 2015
  • Universität Konstanz
    Bachelor of Science (B.Sc.), Chemie
    2010 - 2013

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