Julie Tharin

Global CMC Regulatory Affairs Senior Associate at Actelion (now Janssen Pulmonary Hypertension)
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Contact Information
us****@****om
(386) 825-5501
Location
Basel, Basel, Switzerland, CH
Languages
  • English Full professional proficiency
  • French Native or bilingual proficiency

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Credentials

  • Copywriting
    LiveMentor
  • Facebook : de A à Z
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  • Lancer son activité avec Wordpress
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  • Marketing Digital
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Experience

    • Switzerland
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Global CMC Regulatory Affairs Senior Associate
      • Jul 2021 - Present

      * Coordination of the minor and major variations (type Ia, type IaIN, type II), renewals, commitments, answers to questions* Contact with worldwide affiliates: Europe - US – Canada – Asia Pacific – Latin America - Japan* Writing the quality part of the CTD (e-submission)* Coordination of the submission (commercial, clinical)

    • Global CMC Regulatory Affairs Associate
      • May 2020 - Jun 2021

    • Global CMC Regulatory Affairs Senior Coordinator
      • Jul 2019 - Apr 2020

    • Technical Regulatory Affairs Coordinator
      • Aug 2013 - Mar 2020

    • Online Audio and Video Media
    • Blogueuse : rédaction web, création de contenu, community management
      • Mar 2016 - Present

      Blog Lifestyle, Food et Voyage à Strasbourg : julifestylejls.com* Création de contenu pour les marques* Community management* Gestion d'outil multi-réseaux* Notions de SEO naturel* Veille digitale* Couverture d'évènements* Relation blogueurs Blog Lifestyle, Food et Voyage à Strasbourg : julifestylejls.com* Création de contenu pour les marques* Community management* Gestion d'outil multi-réseaux* Notions de SEO naturel* Veille digitale* Couverture d'évènements* Relation blogueurs

    • Organisatrice d'une soirée blogueurs
      • May 2017 - May 2017

      Organisation d'une soirée blogueurs pour LoebEvents : présentation de la saison d'été du Dôme à Haguenau. Organisation d'une soirée blogueurs pour LoebEvents : présentation de la saison d'été du Dôme à Haguenau.

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Consultancy - Labelling Specialist to support Project Edge Labelling Compliance and Process Review
      • Dec 2012 - Jun 2013

      *Labelling Compliance review:-Confirm categorisation of findings resulting from the Labelling compliance check-Liaises with the different markets when different categorisation of findings have been made and ensures follow-up-Follow up on remediation actions identified during the compliance check *Labelling Compliance review:-Confirm categorisation of findings resulting from the Labelling compliance check-Liaises with the different markets when different categorisation of findings have been made and ensures follow-up-Follow up on remediation actions identified during the compliance check

    • Switzerland
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Trainee in Technical Regulatory Affairs
      • Jan 2012 - Aug 2012

      * Writing the quality part of the CTD (e-submission)* Coordination of the submission (commercial, clinical)* Coordination of the minor and major variations (type Ia, type IaIN, type II), renewals, commitments, answers to questions* Contact with worldwide affiliates: Europe - US – Canada – Asia Pacific – Latin America - Japan * Writing the quality part of the CTD (e-submission)* Coordination of the submission (commercial, clinical)* Coordination of the minor and major variations (type Ia, type IaIN, type II), renewals, commitments, answers to questions* Contact with worldwide affiliates: Europe - US – Canada – Asia Pacific – Latin America - Japan

    • France
    • Staffing and Recruiting
    • 700 & Above Employee
    • Hostess for concert, shows
      • Oct 2010 - Dec 2011

      Verification of tickets, people seating Verification of tickets, people seating

    • Qualified Technician
      • Jul 2010 - Aug 2010

      * Delivery and labelling of blood and other fluids samples* Distribution into the different medical laboratories * Delivery and labelling of blood and other fluids samples* Distribution into the different medical laboratories

    • France
    • Higher Education
    • 700 & Above Employee
    • Intern
      • Apr 2009 - Jun 2009

      Undergraduate IntenshipCell cultures, toxicity tests, tests of the European Pharmacopeia on tablets and powders. Undergraduate IntenshipCell cultures, toxicity tests, tests of the European Pharmacopeia on tablets and powders.

Education

  • Faculty of Pharmacy of Strasbourg
    Master's degree with Merit, Pharmaceutical Engineering
    2010 - 2012
  • University of Strasbourg
    Bachelor's degree, Cellular Biology and Physiology
    2009 - 2010
  • University Institute of Technology Louis Pasteur in Strasbourg
    Undergraduate Degree, Biology Engineering – Food and Biological Industries
    2007 - 2009

Community

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