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

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luogo di lavoro
varese, lombardia
Operai e tecnici specializzati


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):


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.


- 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

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