Regulatory Affairs Specialist

Ozone Laboratories SRL

07-05-2007 | EXPIRA LA 06-06-2007

Job expirat

RESPONSABILITATI

Prepares the files for the registration of products based on the technical data supplied by the manufacturer and accordingly with the legislation and appointments
Evaluates and completes the pharmaco-chemical documentation that needs to be handed out for authorization
Prepares variation documentation for Ozone products
Reports to the manager about the phases of the dossiers, etc
Pre-audit at the manufacturer and assists at the internal or external GMP inspection


CERINTE

Higher education (Medicine, Pharmacy, Chemistry preferably)
Communication abilities
Organizational abilities
Orientation towards objectives
English - advanced
MS Office
Experience in a similar position - at least 1 year


DESCRIEREA FIRMEI

Ozone Laboratories is an international company present in CEE Europe and one of the most dynamic pharmaceutical companies in Romania.