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Qiaowen YANG

ANNEMASSE

En résumé

Mes compétences :
GMP
Analytical skills
EU and worldwide regulations
Pharmaceutcal develoment and production
Regulatory Affairs
CMC writing
Galenic and formulation skills
E-CTD preparation and submission
Module 1 preparation

Entreprises

  • Stragen Pharma SA (Plan-Les-Ouates, GE - Switzerland) - Regulatory Affairs Project Manager - Regional

    2015 - maintenant Responsible management of all regulatory aspects for dedicated markets, including but not limited to France, Switzerland, North Africa, Middle-East
    Regulatory strategy and activities related to various pharmaceutical forms of products and initial MA applications & maintenance of existing registrations (e.g. renewal and variation dossiers preparation and submission)
  • Stragen Pharma SA (Plan-Les-Ouates, GE - Switzerland) - Regulatory Affairs Project Manager

    2012 - maintenant Responsible management of all regulatory aspects for dedicated medicinal products: Regulatory strategy and activities related to new products and maintenance of new and existing registrations - permit business growth and protect current business performance for the national and/or international regions/markets
  • Stragen Pharma SA (Geneva - Switzerland) - Development Project Manager

    2010 - 2012 Timely preparation of high quality drug substance and drug product Quality (CMC) documentation - Act as Quality Expert and support global regulatory submissions
  • Ethypharm (Grand Quevilly, in Normandy, 76 - France) - Galenic Project Manager & PhD Student

    SaintCloud 2006 - 2009 -Management of development/formulation project
    -Formulation and analytical skills: layering of drug substance and film coating of oral dosage forms, HPLC / UV, dissolution, KF, texture analyser, optical microscopy, MEB, thermal analysis (TGA, DSC), Raman spectroscopy, force atomic microscopy, in-vitro drug release using Franz cells, particle size analysis (mastersizer), stability studies
    -Manager experiences of student trainees (various levels: secondary school degree to Master/Engineer Degree)
  • Ethypharm (Houdan, near Paris, 78 - France) - Trainee in Galenic formulation department

    SaintCloud 2006 - 2006 Formation and stability conditions of polymeric film coatings used for oral solid dosage forms
  • Pfizer PGM Amboise (Amboise, near Tours, 37 - France) - Trainee in packaging department

    Paris 2005 - 2005 Improvement of master batch record related to primary and secondary packaging lines of oral dosage forms (capsules, tablets)

Formations

  • Commission Des Professions Medicales MEBEKO - Office Federal De La Santé Publique (Berne)

    Berne 2013 - 2013 Diplôme d'Etat de Pharmacien
  • Université Lille 2 Droit Et Sante

    Lille 2006 - 2009 Doctorat d'Université - PhD GRADE (with disctinction)

    Pharmaceutical Technology - Laboratoire de pharmacotechnie industrielle, INSERM U 1008 - Collaboration with Ethypharm, R&D Centre and College of Pharmacy of Paris, EA 401
    Subject: AQUEOUS POLYMERIC FILM COATINGS OF ORAL DOSAGE FORMS FOR CONTROLLED DRUG DELIVERY
  • Faculté De Pharmacie - Université Paris-Sud XI (Chatenay Malabry)

    Chatenay Malabry 2005 - 2006 Master M2 Recherche, Innovation en biopharmacie - Master Degree in Pharmaceutical sciences, specialization in Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
  • Faculté Des Sciences Pharmaceutiques Et Biologiques - Université De Lille 2

    Lille 1999 - 2006 Diplôme d'Etat de Docteur en Pharmacie - Pharm.D GRADE (2006)

    Pharmacien industriel - specialization in industry - Subject: "Rationalisation de l'utilisation des dispersions aqueuses pour l'enrobage des formes orales à libération prolongée"

    + Diplôme de Maitrise des Sciences Biologiques et Médicales - Master Degree in Medical and Biological Sciences (2005)
  • Lycée Fenelon

    Lille 1996 - 1999 Equivalent to High school diploma in Biology, Chemistry, Physics and Maths (1999)

    Secondary school

Réseau

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