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    Regulatory Affairs Support - Rome, Italia - Viatris

    Viatris
    Viatris Rome, Italia

    6 giorni fa

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    Tempo parziale
    Descrizione
    VIATRIS ITALIA S.R.L.

    At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

    Viatris empowers people worldwide to live healthier at every stage of life.

    We do so via:

    Access – Providing high quality trusted medicines regardless of geography or circumstance;
    Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
    Partnership – Leveraging our collective expertise to connect people to products and services.

    Every day, we rise to the challenge to make a difference and here's how the Regulatory Affairs Support Intern role will make an impact:

    Key responsibilities for this role include:

  • Support for the preparation and filing of variations (paper and electronic)
  • Archiving of regulatory documentation
  • Support in the management of the national phase for Marketing Authorizations.
  • Preparation of Certificate of Pharmaceutical Products (CPP)
  • Preparation of texts in accordance with Farmastampati
  • Product Information review (SmPC, PIL, Labels)
  • Artworks review
  • Internal communications and printed change databases
  • Publications in Gazzetta Ufficiale
  • Internal systems update (RIMS, D2, PDM, Trackwise)

    • The minimum qualifications for this role are:

  • Bachelor degree or higher in science or health related field (Pharmacy or Chemistry and Pharmaceutical Technology (CTF) are preferred); Master degree in Regulatory Affairs would be an asset
  • Previous internship experience in Regulatory Affairs would be an asset
  • General knowledge of the pharmaceutical company
  • Preferably possess following skills: curiosity, motivation, analytical thinking, communication, problem solving, team working, quality and compliance orientation, priority setting and time management capabilities, adaptability, driving for results, personal learning
  • Good knowledge of Windows and Microsoft Office
  • Proficiency in speaking, comprehending, reading and writing English and Italian is required

    • At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

    Viatris is an Equal Opportunity Employer.

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