Baptiste BARBIER

Baptiste BARBIER

Regulatory SItre Officer Apprentice, Sanofi

En poste chez Sanofi

Précédents : Sanofi, Centre Hospitalo-Universitaire CHU - Dijon


En formation chez Université De Bourgogne

Précédents : Lycée Saint Francois De Sales


    En résumé

    As a future graduate (Pharm.D.) in October 2014, I am looking for a position as a Regulatory Affairs Junior Associate. I am currently a Regulatory Site Officer at Sanofi near Dijon (France). I am in charge of type I & II variation dossiers, Module 3 of the CTD, renewals of marketing authorizations and site transfer management. In October 2014, I will have had sixteen months’ practical experience in this domain. I am personally very interested in the international context of Regulatory Affairs. I am young, dynamic and mobile. I am strongly self-motivated and I like working in a team. Working in a Regulatory Affairs Department will give me the opportunity to develop my skills in the company. It will also satisfy my deep interest in a foreign culture and add an international dimension to my experience in my home country, France.



Regulatory Site Officer Apprentice

Chez Sanofi

De octobre 2013 à aujourd'hui
• Management, preparation and ensuring of the timely completion CMC-related regulatory submissions (local and international) • Regulatory representative for the maintenance of drug products • Reviewing technical reports and summary documents (chemistry, manufacturing and analytical controls) to ...
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Université De Bourgogne, Dijon

Master's degree, Operational & International Management in the Healthcare Industry, UFR Pharmacie

De septembre 2013 à aujourd'hui
• Regulatory Affairs (Development & International Registration, Supports as CTD & Pharmacopoeias) • Quality Assurance (Qualifications & Validations, CAPA, Audit, Quality Control, GMP) • Team Management • English (TOEIC 805)

Université De Bourgogne, Dijon

Pharm.D, UFR Pharmacie

De septembre 2008 à aujourd'hui
Biomedical, pharmaceutical and clinical sciences. Other courses include pharmacotherapeutics, pathophysiology, pharmacokinetics, physical assessment, clinical trials, immunopathology statistics, biotechnologies, pharmacy management • Teaching unit: Pathophysiology of Cardiovascular Diseases • ...
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Trainee in Regulatory Affairs/Quality Systems

Chez Sanofi

De juin 2013 à octobre 2013
• Submission of new applications and variations - CMC/CTD • Change control management • Follow-up & drafting of variations (Types I & II) about transfer of injectable products • Relationships with Global Regulatory Affairs (GRA), with other Regulatory Affairs Officers (RSO) and with Industrial ...
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Trainee in a Cardiovascular Surgery Unit

Chez Centre Hospitalo-Universitaire CHU - Dijon

De janvier 2013 à mars 2013
• Talking about treatments with doctors & professors • Follow-up of operations in a surgical ward • Preparation of patients’ treatments • Talks with patients about their disease and complications with treatments • Reports on pharmacovigilance issues

Trainee in a Mycology Laboratory

Chez Centre Hospitalo-Universitaire CHU - Dijon

De octobre 2012 à décembre 2012
• Diagnostics & interpretation in fungal infections and reporting the results (to clinical units) • Memorandum ’Setting up of Quality Accreditation for the Mycology Analysis Laboratory of the Teaching Hospital in Dijon’

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Centres d'intérêt

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