Senior Global Labelling Coordinator

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. 

Your Experience: 

Bachelor’s degree preferred, with pharmaceutical industry experience preferably in Regulatory Affairs. 

Prior experience in translations management preferred. 

Good communication and negotiation skills. 

Fluency in English. Knowledge of other languages is desirable. 

Ability to work in a complex, cross functional working environment.