REGULATORY AFFAIRS SPECIALIST

ZENTIVA S.A.

28-02-2006 | EXPIRA LA 30-03-2006

Job expirat

RESPONSABILITATI

- Elaborates drug registration dossiers for all types of applications (new registrations, renewals, variations) in NTA and CTD format
- Supervises transmission on time of drug authorization/reauthorization dossiers and of the information requested by authorities
- Creates technical specification for final products, according to the valid marketing authorization
- Draws up expert reports for the chemical and pharmaceutical part of the drug registration dossier
- Administrates documents and data regarding drug registration activity


CERINTE

- University degree (pharmacist, chemist, chemist engineer, biologist)
- Relevant experience on a similar position
- English ¿ advanced level
- PC literacy (MS Word, Excel)
- Communication skills
- Details oriented
- Meticulous
- Rigorous
- Team spirit


BENEFICII OFERITE

We invite all those interested in the position and that meet the above mentioned requirements to send us their application (CV and letter of intent).
Only the suitable candidates will be contacted.


DESCRIEREA FIRMEI

Zentiva este leader on pharmaceutical market from Eastern and Central Europe