Julie Tharin
Global CMC Regulatory Affairs Senior Associate at Actelion (now Janssen Pulmonary Hypertension)- Claim this Profile
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English Full professional proficiency
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French Native or bilingual proficiency
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Bio
Credentials
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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
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Actelion (now Janssen Pulmonary Hypertension)
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Switzerland
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Pharmaceutical Manufacturing
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500 - 600 Employee
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Global CMC Regulatory Affairs Senior Associate
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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)
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Global CMC Regulatory Affairs Associate
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May 2020 - Jun 2021
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Global CMC Regulatory Affairs Senior Coordinator
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Jul 2019 - Apr 2020
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Technical Regulatory Affairs Coordinator
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Aug 2013 - Mar 2020
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JuLifeStyle JLS
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Online Audio and Video Media
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Blogueuse : rédaction web, création de contenu, community management
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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
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Organisatrice d'une soirée blogueurs
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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.
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Consultancy - Labelling Specialist to support Project Edge Labelling Compliance and Process Review
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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
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Actelion (now Janssen Pulmonary Hypertension)
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Switzerland
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Pharmaceutical Manufacturing
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500 - 600 Employee
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Trainee in Technical Regulatory Affairs
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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
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SUPPLAY
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France
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Staffing and Recruiting
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700 & Above Employee
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Hostess for concert, shows
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Oct 2010 - Dec 2011
Verification of tickets, people seating Verification of tickets, people seating
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Qualified Technician
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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
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University of Strasbourg
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France
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Higher Education
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700 & Above Employee
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Intern
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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.
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Education
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Faculty of Pharmacy of Strasbourg
Master's degree with Merit, Pharmaceutical Engineering -
University of Strasbourg
Bachelor's degree, Cellular Biology and Physiology -
University Institute of Technology Louis Pasteur in Strasbourg
Undergraduate Degree, Biology Engineering – Food and Biological Industries