Gaëlle ENDERLIN

Global Therapeutic Area Lead chez Novartis

Switzerland

About

Pharmacist Master`s Degree in European Union Law and Regulatory Affairs

Experience

  • Novartis (15 yrs 7 mos)
    • Global Therapeutic Area Lead (Regulatory)
      Mar 2024 - Present · 2 yrs 5 mos

    • Global Program Regulatory Director
      Apr 2020 - Mar 2024 · 4 yrs

    • Senior Global Program Regulatory Manager
      Apr 2018 - Apr 2020 · 2 yrs 1 mo

  • Part-time lecturer at Université de Strasbourg
    Sep 2010 - Aug 2018 · 8 yrs

    • Creator and Co-Head of the teaching unit “Clinical Trials regulations” o Lectures and tutorials about Clinical Trials regulations in Europe (approximately 20 hours per year) o Training of students

  • Internship in the laboratory “Pharmaceutical Law and Economics” at Laboratoire de Droit et Economie Pharmaceutiques (EA 3396), Directeur Jean-Yves Pabst
    Mar 2010 - Aug 2010 · 6 mos

    • Correction of a Common Technical Document (Module 2.3 – Quality Overall Summary) • Correction of labels according to French Regulations and regulatory monitoring • Setting up of a new teaching unit about “Clinical trials regulations”: working out of course and tutorials, training of students

  • Hopitaux Universitaires de Strasbourg (7 mos)
    • Internship
      Dec 2009 - Mar 2010 · 4 mos

      Pharmacy student in "Internal medicine": - Study of medicinal interactions, - Control of prescriptions - Presentation of clinical cases

    • Internship
      Sep 2009 - Dec 2009 · 4 mos

      Pharmacy student in the Pharmacovigilance center (drug safety): - Analysis of adverse drug reactions, - Management of drug safety related questions from HCPs, - PSUR analysis, - Renewals - Documentary research