Samira Hadj Sadok's Email Addresses & Phone Numbers

Global Regulatory Affairs Coordinator @ Medicines - Medical Devices From August 2015 to Present (5 months) Gent Area, BelgiumRegulatory Affairs Manager @ - Peparation, follow up and update of the registration dossiers (CTD format) in the following regions: * Europe/Eastern Europe (Russia, Ukraine, CIS Countries) * North America: US and Canada * Asia: China, Taiwan and all...

Global Regulatory Affairs Coordinator @ Medicines - Medical Devices From August 2015 to Present (5 months) Gent Area, BelgiumRegulatory Affairs Manager @ - Peparation, follow up and update of the registration dossiers (CTD format) in the following regions: * Europe/Eastern Europe (Russia, Ukraine, CIS Countries) * North America: US and Canada * Asia: China, Taiwan and all ASEAN countries * Middle East and North Africa - Handling changes and variations - Regulatory watch and surveillance - Regulatory contact during the inspections conducted by health authorities (FDA...) - Lobbying within professional associations From October 2012 to August 2015 (2 years 11 months) Lille Area, FranceRegulatory Affairs @ In the roll out of the new global Sanofi regulatory affairs submission tracking database dedicated to all submitted and approved products worldwide throughout their lifecycle from planned submission to their withdraw: - Redaction and update of Sanofi Pasteur business processes: initial submission (National, CP, DCP and MRP), variations, renewal, exchanges with health authorities, batch recalls… - Development of user guidances for the different processes - Communication regarding this new project via newsletters and animated power point presentations From March 2012 to August 2012 (6 months) Lyon Area, FrancePharmacist @ - Management of medicinal products with a Temporary Authorization for Use - Oncology clinical pharmacy - Prescriptions' validation - Renconstitution of cytostatic drugs From September 2011 to February 2012 (6 months) Lyon Area, FranceClinical pharmacology and pharmacogenetics @ - Study the eventual association between genes’ polymorphisms involved in the p53 pathway (MDM4 and TP53BP1), in breast cancer, and the benefit of a neo-adjuvant chemotherapy based on FEC (5-Fluorouracile, Epirubicin and Cyclophosphamide) or TAX (Docetaxel and Epirubicin) - Objectives: Evaluation of the patients’ clinical and pathological response after 6 neoadjuvant chemotherapy cycles as well as the definition of the polymorphisms associated with a complete clinical or pathological response. From October 2010 to September 2011 (1 year) Bordeaux Area, FranceQuality Control @ - Validation of analytical procedures - Control of the starting materials, intermediates, bulk and finished drug products - Conduct of stability studies From March 2010 to October 2010 (8 months) TunisiaProduction @ - Writing, follow up and update of production and storage procedures - Ensure the compliance with Good Manufacturing Practices From September 2009 to February 2010 (6 months) TunisiaECA Regulatory Affairs Manager @ European Compliance Academy (ECA) From 2013 to 2015 Master's Degree: European Diploma in Pharmaceutical Medicine (EUDIPHARM), Regulatory Affairs - Clinical Development @ Industrial Pharmacy Institute of Lyon (IPIL) - France From 2011 to 2012 University Diploma, Oncology clinical pharmacy @ Victor Segalen University Bordeaux II - France From 2010 to 2011 Master's Degree, Drug Development @ Faculty of Pharmacy - Tunisia in cooperation with Victor Segalen University Bordeaux II - France From 2009 to 2011 Master's Degree, Quality Management @ Faculty of Pharmacy - Tunisia From 2008 to 2009 National Diploma in Pharmacy @ Faculty of Pharmacy - Tunisia From 2002 to 2008 Samira Hadj Sadok is skilled in: Regulatory Affairs, Pharmaceutical Industry, GMP, Pharmaceutics, Regulatory Submissions, FDA, Regulatory Requirements, Clinical Development, Clinical Trials, Drug Development, Oncologie, Développement clinique, Affaires réglementaires, BPF, Développement de médicament