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Ipsen
- Global Regulatory Officer - Intercontinental
Boulogne-Billancourt
2015 - maintenant
Within the neurology area, responsible for the deployement of the CMC strategy (variations,RtQ,..) of one of the main company product indicated for the treatment of spasms, dystonias, hyperhydrosis and aesthetic.
It covers the following regions:
- Pacific(NZ and AU)
- Asia with the exclusion of Japan
- LATAM
- Middle east
- Maghreb
Coordination role between Global CMC team and Local RA officers.
Management of the submission of the new registration, variations, RtQ according to local regulations.
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Sanofi
- Global Regulatory Affairs Pharmacist
Paris
2014 - 2015
- Corporate project management:
. Supergroupings CP, MRP/DCP : « corporate packages » preparation, management of submission with affiliates;
. Referrals Art. 31 & 5(3), PSUR assessment – response to PRAC rapporteur questions: internal diffusion to relevant department, coordination of the response document and submission of the response dossier to competent authorities, contact with PTL (EMA);
. Writing internal SOP.
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Pfizer
- Pharmacien Affaires Réglementaires
Paris
2012 - 2014
Pfizer is one of the worldwide major pharmaceutical company.
Attached to the regulatory affairs department, I carried out the following activities :
- Management of a portfolio of medicinal products (main therapeutic areas: cardiology/oncology):
. Registration activities under European legislation (NP, DCP, MRP, CP): MA applications, variations, worksharing, referrals;
. Follow-up of dossiers (Health Authorities queries);
. Product information: preparation and submission of update to SPC and PIL (DMI), creation and update of prescribing information text, review and validation of artwork;
. Regulatory compliance: internal databases update, regulatory monitoring.
- Cross-functional activities:
. Coordination of temporary-use authorization and recommendation (ATU/RTU)
. Compilation of all pending product information variations;
. Writing and update of internal SOP;
. Management of PSMF introduction variation for the whole Pfizer products registered within national procedure.
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EG LABO - Laboratoires EuroGenerics
- Assistant Affaires Réglementaires
2012 - 2012
EG LABO -Laboratoires Eurogenerics is a company specialized in generic medicines whose turnover is now over 100 millions euros. The regulatory affairs represent more than 500 products.
Attached to the regulatory affairs departement, I carried out the following activities :
- preparation and submission of variation within both french and european classifications (update of CEP, DMF, change in medicinal product maufacturer, active substance transfer,...)
- preparation and submission of MA renewal within national/european procedure (MRP, DCP)
- drafting and update of quality assurance internal procedures
- submission in electronic format (eCTD)
- market access activities (social insurance registration,...)
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Bayer Santé Familiale
- Assistant Qualité et Excellence Opérationnelle
Lyon
2011 - 2011
Bayer Santé Familiale belongs to the german company Bayer.
It's mainly producing over-the-counter medicines and dietary supplements.
Attached to Quality & Operational Excellence department, I carried out two main tasks :
- creation of a database of regulatory and quality documents
- writing of the "raw material quality report" (traceability documents)
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Hospices Civils de Lyon
- Stagiaire à la radiopharmacie
Lyon
2010 - 2011
Attached to the radiopharmacy department :
- preparing radiopharmaceuticals medicines
- monitoring quality of radiopharmaceuticals medicines (gamma spectrometry, TLC-radiochromatograph,...)
- evaluating and validating new methods of quality control
- drawing up a thesis on the validation of this new controls
- medicals activities : patient therapeutic education,...
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Faculté de pharmacie de Ljubljana (Slovénie)
- Assistant de recherche
2010 - 2010
- synthesis of antibacterian molecules
- assistance in a research thesis (PhD)
During this experience, I developped my ability to work in english.
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Diverses pharmacies
- Assistant Pharmacien
2007 - 2010
- dispensing prescriptions to patients quickly and accurately
- advising patients on correct use of over-the-counter medications
- demonstrating correct use of specific medication devices
- receiving pharmaceutical sales representative
