Experience

MSD Animal Health Italia

• Italy
• Veterinary Services
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Dec 2011 - Present

  Responsible for: - preparing and submitting regulatory documents to the local authorities and to the EMA, related to new applications, variations, renewals, PSURs etc.; - assisting in department administrative tasks, such as meeting arrangements, coordination of agendas, taking and circulating minutes; - building and maintaining marketing authorization filing and approval binders and keeping regulatory databases and systems updated and complete; - implementing updated regulatory documentation; - preparing, translating and checking the SPC and Product Literature for the veterinary medicinal products, in connection with submission of Marketing Authorization applications, variations, renewals and PSURs, ensuring quality assurance including linguistic review of these documents; - ensuring that package artwork of products is developed in a timely and correct manner and updated according to the requirements of national and European authorities; - coordinating and team-working with other departments such as Marketing, Purchasing, Sales etc. with regard to the implementation of variation, management of product recalls from the market and of packaging re-works; - assisting and supporting the local DPOC during the standard pharmacovigilance operations; - reviewing and approving any kind of material intended for marketing promotion and/or technical and scientific information. Show less


Huber Italia S.p.A.
• Italy
• Chemical Manufacturing
• 1 - 100 Employee
• Laboratory Technician

  • Jan 2009 - Nov 2011

Formevet S.r.l.
• Sales Representative

  • Jan 2008 - Jul 2008

UnireLab S.r.l.
• Italy
• Veterinary Services
• 1 - 100 Employee
• Laboratory Technician (internship)

  • Oct 2007 - Dec 2007

Clinica Veterinaria Bustese
• Veterinarian

  • Mar 2007 - Sep 2007