Qiaowen YANG

En résumé

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

• Assouly ALBERT

• Emilie LEPILLEUR

• Frédéric MALLET

• Jiang CHANG

• Louise VALLÉE

• Nadege TCHAPA MISSEY

• Pierre BERGER-BY

• Pq And Me CONSULTING

• Stephanie TIQUET

• Virginie BUSIGNIES