Associate Registration Officer
2 months ago
1478 Generics [U.K.] Ltd.
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 Associate Registration Officer (12 months fixed-term) role will make an impact:
Key responsibilities for this role include:
- Developing, building and maintaining a TEAMS site structure for the project, based on individual markets feedback- Verifying and updating the Master project tracker against MyPortfolio- Taking country-specific extracts from the Master Schedule tracker and saving them to TEAMS as required- Participating in meetings with Management Team and affiliates as appropriate- Tracking the progress of variation submissions- Identifying and proposing groupings of name changes variation to ensure cost savings- Identifying and highlighting issues preventing the submission of name change variation upon feedback from market and coordinator- Align with Regulatory leads on submission planning- Assisting with the preparation of PP presentations and visuals/charts of submissions tracking- Setting up meeting invitations with affiliates and keeping minutes
The minimum qualifications for this role are:
- Basic understanding of European Regulatory affairs and the variations guideline, with particular focus on Acceptable groupings- Good knowledge of excel and IT literacy- Good use of Powerpoint- Eye for detail- Ability to work under tight deadlines, while keeping a flexible mindset.- Good communication and teamwork skills- Fluent English
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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