Consultant en affaires réglementaires et qualite

• Jun 2021 - Present

Regulatory affairs specialist

• Jan 2020 - Mar 2021

Chargé d'affaires réglementaires

• Dec 2017 - Dec 2019

Chargé d'affaires réglementaires dans une société d'imagerie médicale, gestion de produit de type Im à IIb. Rédaction des STED, matériovigilance, PMS et veille réglementaire sont mes principales activités. Chargé d'affaires réglementaires dans une société d'imagerie médicale, gestion de produit de type Im à IIb. Rédaction des STED, matériovigilance, PMS et veille réglementaire sont mes principales activités.

Consultant en affaires réglementaires

• Jan 2017 - Nov 2017

Regulatory Affairs Consultant

• Feb 2014 - Nov 2017

Support Client of Caduceum, in regulatory affairs for Medical Devices, Pharmaceutical Industry, or Cosmetics. Support Client of Caduceum, in regulatory affairs for Medical Devices, Pharmaceutical Industry, or Cosmetics.

Rédacteur technico réglementaire

• Sep 2016 - Dec 2016

Rédaction des modules 2, 3, 4, et 5 du CTD pour des médicaments homéopathiques pour soumission à la belgique des dossiers d'enregistrements homéopathiques. Rédaction des modules 2, 3, 4, et 5 du CTD pour des médicaments homéopathiques pour soumission à la belgique des dossiers d'enregistrements homéopathiques.

regulatory affairs, CMC consultant

• Aug 2015 - Jul 2016

Mise à jour de module 2 et 3 du CTD pour un grouping de variations Mise à jour de module 2 et 3 du CTD pour un grouping de variations

Regulatory affairs responsible (consultant)

• May 2015 - Oct 2015

Consultant in Regulatory Affairs

• Jun 2014 - May 2015

Consultant Regulatory Affairs

• Jun 2014 - Jun 2014

Update of Risk analysis and Clinical report before CE renewal Update of Risk analysis and Clinical report before CE renewal

Regulatory Affairs Consultant

• Feb 2014 - May 2014

Support Health Industry in Regulatory Affairs: _Redact 2 CTD for medical devices following a change in classification by Canadian Health Autorities _Audit of Regulatory affairs and Quality Assurance services for Medical Device IVD manufacturer. Support Health Industry in Regulatory Affairs: _Redact 2 CTD for medical devices following a change in classification by Canadian Health Autorities _Audit of Regulatory affairs and Quality Assurance services for Medical Device IVD manufacturer.

Regulatory affairs consultant

• May 2013 - Feb 2014

_ Regulatory affairs support to pharmaceuticals company

Regulatory Affairs consultant

• Jun 2011 - Apr 2013

_Administrative variation in EU on National, DCP, MRP product_Manage submission to international country of commitment and variation dossier_Check the compliance with the local company around the world_Collect data about EU regulatory in aim to create a regulatory database for altran Belgium

Regulatory Affairs consultant

• Aug 2013 - Dec 2013

prepare WHO product summary files reassessment for 3 vaccins, Collect all document necessary to this kind of dossier, and manage writing and compliaance with PQVAR. prepare WHO product summary files reassessment for 3 vaccins, Collect all document necessary to this kind of dossier, and manage writing and compliaance with PQVAR.

Regulatory affairs engeneer

• May 2013 - Jul 2013

Check compliance between technical documentation and MA dossier Check compliance between technical documentation and MA dossier

Regulatory affairs support VRM

• Dec 2011 - Jan 2013

_ Prepare and dispatch post approval commitment to EU and international country_Prepare and submit/dispatch variation for cross product team to EU country, by MRP process and Super grouping process._Update regulatory data base_check data and validate them following regulatory data base migration from lotus note to liquent insight.

Regulatory affairs manager

• Sep 2011 - Dec 2011

Prepare and submit a 1Ain variation for address change and name change of belgium marketing holder for All pharmaceuticals product authorized in Belgium and Luxembourg trought a groupped variation for national product. And trought a supergroupped variation for mutual recognition product

Regulatory affairs trainee intercontinental

• Mar 2009 - Sep 2009

Manage planning and submission strategy of a type IIb Medical Device _Regulatory survey about sunset clause, Medical device Regulation, OTC medecine. For the coutnries of Middle East, Latin America and Africa Manage planning and submission strategy of a type IIb Medical Device _Regulatory survey about sunset clause, Medical device Regulation, OTC medecine. For the coutnries of Middle East, Latin America and Africa