Regulatory Affairs Support

4 giorni fa

Roma, Italia Viatris A tempo pieno

7092 Mylan 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 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 Products (CPP)
- Preparation of texts in accordance with Farmastampati
- Printed 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 is required

At Viatris, we offer competitive salaries, benefits and an 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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