Regulatory Specialist - Labelling Coordination

Job Purpose:

Provide support to GRA Labelling staff to ensure the timely management and communication of global, country and regional Product Information/labelling documentation.

Effective coordination, communication and maintenance of labelling documents and data in regulatory systems in accordance with defined standards and processes.

Key Responsibilities

• Efficient coordination and communication of labelling documentation such as Global Product Information (PI), International PI, Country Labelling Differences, Responses to Agency Labelling Questions, EU PI (including translations) and US PI
• Providing support to GRA Labelling staff to ensure the quality and consistency of labelling document content including editing Global/regional/country PI, generation of Country Labelling Differences and periodic reports, and management of labelling artwork in accordance with relevant processes, templates and standards
• Storage of labelling documentation in regulatory systems including communication of approved Global and regional/country PI
• Efficient communication with GSK staff (including Global Regulatory Affairs, Global safety and medical and Local Operating Companies) to collate, compile and perform quality checks of labelling documents
• Management of GRA Labelling data in regulatory systems such as: PRION, GRACE, OSCAR, IMMS, eCTD Backbone, OPAL, HARMONY.
• Supporting GRA-labelling processes and systems in accordance with GSK policies and procedures
• Supporting other labelling functions and participation in other projects and activities as needed, such as contributing to the implementation of changes to processes within GRA Labelling.