Summary

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.

To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients
even faster.

We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

Apply today and welcome to where we thrive together!

About the Role

This role offers hybrid working, requiring 3 days per week in our White City, London office.

As Global Labelling Coordinator you will be responsible for providing specialised support to RA Global Labelling Managers and the Head of Global Labelling related to the creation and maintenance of core labelling packages (including Core Data Sheets) for development programmes and marketed products including the coordination of global labelling activities according to regulatory requirements and company standards to ensure timely and compliant regulatory submissions worldwide.

• Support the creation and maintenance of assigned labelling projects to enable worldwide regulatory submissions.
• Independently coordinate the timely delivery of compliant documentation (Clinical Overviews, Non-clinical Overviews, SCE, SCS, PSUR, published literature, Expert CVs, Signature Pages, etc.) to support regulatory labelling submissions worldwide.
• Guide and support the Global Labelling Managers, RA Managers and cross-functional experts with the review of documents to ensure compliance with regulatory requirements and company standards, including formal QC.
• Maintain current information on the labelling project in planning tools and support compliance with required timelines.
• Coordinate planning and scheduling of topics and manage logistics of the
• Global Labelling Committee and joint labelling committee/safety board meetings including overall management of meeting minutes.
• Provide support during HA inspections and audits, such as compiling and archiving documentation, etc.
• Act as administrator and superuser for regulatory and labelling-specific databases.
• Support Translation Managers by creating regulatory-compliant (bookmarks, formatting, etc.) Word and pdf files for submission to the European Medicines Agency (EMA), adhering to required timelines.
• Independently prepare submission- ready files of amended translations for submissions involving minor, non-linguistic changes.
• Manage contact and delivery with external vendors, managing all aspects of workflow, payments for non-CP translation activities.

• Bachelor's degree preferred, with pharmaceutical industry experience preferably in Regulatory Affairs.
• Good communication and negotiation skills.
• Prior experience in translations management preferred.
• Fluency in English (Knowledge of other languages is desirable).
• Ability to work in a complex, cross functional working environment.