regulatory affairs (moduls 4 and 5, fda and/or swissmedic relations) svizzera a VARESE

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dettagli offerta

pubblicato
luogo di lavoro
varese, lombardia
settore
Operai e tecnici specializzati
tipologia
indeterminato
riferimento
CX66834

descrizione

For our estimated Client operating in Pharma Industry, we are currently looking for an experienced Regulatory Affairs Officer. The candidate has developed during his/her professional path proven experience and relations with FDA and/or Swissmedic and is capable of adopting a full job-commitment, considering both the technical/operative aspects and at the same time the more strategic ones. In particular the candidate will be able to manage autonomously the modules 4 and 5.

He/She wil be inserted in a very skilled team and stimulating work environment, and his/her main responsibilities will be (but not limited to):

responsabilità

managing regulatory procedures and requests;

- registration and commercialization of pharmaceutical and biotechnological products of the Company;

- obtaining authorizations requested by the Company and relevant Authorities in Switzerland and in international environment.

competenze

- Minimum 5 years of proven experience in Regulatory Affairs role, preferably inside productive context;

- Scientific Degree (e.g. Pharmacy, Chemistry and Pharmaceutical Technology, Biology, Biotechnology, Medicine);

- Must: proven experience of relations with FDA and/or Swissmedic and of managing autonomously modules 4 and 5

- Experience in managing of pre-clinic and clinic sections of registration dossiers;

- Good knowledge and usage of main IT tools and Regulatory Affairs software (e.g. e-CTD);

- Good and technical/professional knowledge of English language (written and spoken).

We offer appealing work environment, full-time permanent contract, interesting salary package and social conditions

livello di studio

Laurea specialistica o a ciclo unico
I candidati ambosessi (L.903/77) sono invitati a leggere l’informativa sulla privacy ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).