VIE Regulatory Affairs Analyst H/F

Description de l'offre

Informations générales

Référence

2017-3241

Date de parution

08/09/2017

Branche

Pharmaceutique

Société

ROVAFARM ARGENTINA S A

Description du poste

Intitulé du poste

VIE Regulatory Affairs Analyst H/F

Contrat

VIE

Durée du contrat

24

Taux d'activité

Temps plein

Mission

Attached to the Regulatory Affairs department for Pierre Fabre Pharmaceutical and cosmetic branches and in close collaboration with strategic coordination, you will have as mission to contribute in the ensure regulatory activities for the pharmaceutical and cosmetic branches PFMS and PFDC located in Argentina, for products registration and the cycle time of the products.

To this end you:

- Contribute for the organization of the collection and the developments analysis of drugs and cosmetic regulations in Argentina;
- Perform tracking to transmit on a quarterly basis a report of activities to the central Regulatory Affairs department;
- Collaborate to the management of Administrative files and documentation system;
- Assist in the relations between Corporate Regulatory Affairs Department and Local Regulatory Affairs Department;
- Participate to the compilation of preparation files for the submission of new MA and variations for Pharma and Cosmetic Products ;
- Participate in any meetings to share developments in international regulations and the terms of organization/operation within PFMS and PFDC branches;
- Create a local database and a regular update of all new adverse notified on pharmaceutical and cosmetic product and its follow-up;

Profil

- Scientific Master Degree (Pharmacist ie) or equivalent (Scientific Degree)
- Minimum of 1 year experience in pharmaceutical and/or cosmetic industry in Regulatory Affairs Department
- Organizational and administrative capacity
- Rigorous
- Team Spirit, result oriented
- Analytical ability

Localisation du poste

Localisation du poste

Amériques, Argentine

Lieu de travail

CABA

Critères candidat

Niveau d'études minimum requis

Bac +4 / Bac +5

Diplôme

4-Maîtrise/Master/DEA/DESS/ESC/Ingénieur

Niveau d'expérience minimum requis

1 an ou plus

Langues

Espagnol (4 - Courant)

Demandeur

Date de prise de fonction souhaitée

01/11/2017

Suivi par

Recruteur principal

Fabien DUFFOUR