REGULATORY AFFAIRS SPECIALIST

MEDIPLUS EXIM SA

18-03-2008 | EXPIRA LA 17-04-2008

Job expirat

RESPONSABILITATI

- Preparing and/ or evaluating the documentation files for registration, re-authorization of the products;
- Following-up of the registration process and all legislative requirements connected;
- Translating into Romanian all documents required (summary of product characteristics, patient information leaflet, packaging data, etc.);
- Submitting licence applications and documentation to the authorities to strict deadlines;
- Performing pharmacovigilance activities


CERINTE

- University Degree in Pharmacy, Medicine, Chemistry, Biology or Biochemistry;
- Minimum 3 years experience in a similar position;
- Thorough knowledge of the legislation regarding medicines, food supplements, medical devices, cosmetic products authorizations/ notification;
- Excellent language skills in English
- Good Computer proficiency
- Dynamic and adaptive personality


DESCRIEREA FIRMEI

Mediplus Exim Srl este cel mai mare distribuitor de medicamente din Romania si este parte componenta a grupului A&D Pharma alaturi de o puternica retea de farmacii, Sensiblu SRL.