Regulatory Affairs Support
4 giorni fa
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.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
- Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Support role will make an impact:
- Support for the preparation and filing of variations (paper and electronic)- Support for the preparation of payment for regulatory submission- Archiving of regulatory documentation- Support in the management of the national phase for Marketing Authorizations.- Preparation of Certificate of Products (CPP) and submission to AIFA- Preparation of texts in accordance with Farmastampati- Printed review (SmPC, PIL, Labels) according QRD template- Artworks review- Internal communications and printed change databases- Publications in Gazzetta Ufficiale- Internal systems update (RIMS, D2, Trackwise)
About Your Skills & Experience- 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
Diversity & Inclusion at Viatris
- At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visitSustainability at Viatris
- Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit 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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