Marly-le-Roi 2014 - maintenantRegulatory affairs in a manufacturing site:
• Redaction of variations and module 3 of MA files for launches, renewals
• eCTD (Module 3)
• Regulatory Affairs and Regulatory affairs strategy
• Compliance with pharmaceutical industry standards (GMP, ICH Guidelines,…)
• Packaging compliance and safety
• Artwork and pack management
• Pharmacopoeias compliance (Ph Eur, USP, BP, JP,…)
• Monitoring and regulatory intelligence
• Regulatory Operations and Regulatory monitoring
• Quality Assurance (Quality Alerts,…)
• Responses to pharmaceutical issues (from Health Authorities and/or Health Professional,…)
• Responses to questions (CMC, Module 3, CEP, compliance statements)
• Redaction, Updating and Verification of SOPs (Standards Operating Procedures) concerning Regulatory Affairs and Quality Control items
Type of products: Finished products, Raw materials, premixes
Internal/external contacts: Worldwide
Quimdis SAS
- Chargé d'Affaires Réglementaires
2013 - 2014• Regulatory Affairs strategy concerning raw materials for pharmaceutical use (API, Excipients, plant extracts,…)
• Regulatory Affairs strategy concerning raw materials for veterinary use (veterinary drugs)
• European Regulations (Directive 2011/61/EU,…)
• Regulatory monitoring and pharmacopoeias compliance
• Monitoring and regulatory intelligence
• Quality Assurance
• Editing and verification of the technical documents (specification data sheet, certificates of analysis, MSDS,…)
• Declaration and tele-registration of raw materials on the ANSM site (Health Authorities in France)
• Regulatory Affairs strategy concerning cosmetics (REACH, Cosmetics Regulation on animal testing,…)
Type of products: Raw materials, premixes
Internal/external contacts: Worldwide
Faculté de Pharmacie
- Etudiant
2012 - 2012Travaux de recherche;
- Développement d'un dentifrice à base d'algues brunes, contraintes réglementaires et volet marketing/analyse du marché des produits cosmétiques.
- Développement d'un produit destiné aux personnes atteintes de
MICI (Maladies Inflammatoires Chroniques de l'Intestin), contraintes
réglementaires des compléments alimentaires et aliments fonctionnels.
