Regulatory Affairs Manager (FDA and/or Swissmedic proven relations) in Lugano

veröffentlicht
Kontakt
Andrea Pace, Lugano
Jobtyp
Indeterminato
jetzt bewerben

job details

veröffentlicht
Ort
Lugano, Tessin
Sektor
Life Sciences
Jobtyp
Indeterminato
Referenznummer
204823-1
Kontakt
Andrea Pace, Lugano
Telefon
091 922 21 50
jetzt bewerben

Stellenbeschreibung

For our estimated Client operating in Pharma Industry, we are currently looking for a Regulatory Affairs Manager. 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.

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.   

 

Qualifikation

- 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;

- 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.

If in line with the requisites and interested to go deep into details, don't hesitate to contact and send your up-to-date CV to Mr. Andrea Pace: andrea.pace@randstad.ch