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Regulatory Affairs Specialist
To enhance the structure of the Milan office, Pharma D&S, a services company for the pharmaceutical sector, is looking for a regulatory affairs specialist.
The candidate we are looking for must have direct knowledge of the entire regulatory process and, under the supervision of the Manager and with the support of the central structure, will be responsible for:
– activities at client companies
– review Modules 1-5;
– prepare Modules 1;
– prepare documentation for setting up variations;
– GAP analysis
The ideal candidate is a graduate in scientific disciplines who has gained 2/3 years of experience in the role of Regulatory Affairs Officer in pharmaceutical companies.
It's requested:
– an excellent knowledge of the ICH/EU guidelines, European and Italian legislation relating to medicines;
– good knowledge of pharmaceutical technology topics, GMP and ability to update the technical documentation on the occasion of applications for AIC variation;
– a good knowledge of the Italian legislation relating to Medicines;
– good knowledge of the English language (written and spoken);
– aptitude for interpersonal relationships, marked propensity for team work, result orientation and reliability.
– experience in Mutual Recognition and National procedures
Any experience in decentralized procedures and electronic documentation management is preferred.
Pharma D&S srl
City: Gorgonzola MI
References The research is aimed at people of both sexes (L. 903/77). Interested parties are requested to send a detailed curriculum vitae, with the authorization to process personal data (Legislative Decree 276/2003) to the following address pharmades@pharmades.it
email: pharmades@pharmades.it



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Senior CRA
Think you never have time for family or friends and the only thing you have in life is work? Feel like finding a good balance between your life and work? Working from home can be a solution to these problems. Our client is offering a Home Based Clinical Leader position.
This position offers the opportunity to be able to work from home and finally find the right work-life balance. This position is ideal for a CRA with 3 years of clinical monitoring experience.
The main requests for this role are
– Good experience in the field of clinical research
– Good knowledge of English
– Good experience as clinical monitor
Nonstop Pharmaceutical Recruitment
References For more information on this position contact John Lavarino on +44(0)207 940 2106 or email j.lavarino@nonstop-pharma.com
email: j.lavarino@nonstop-pharma.com

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco