Regulatory Specialist III, Country Labelling

Key Responsibilities ? :

Author and compile Regional / Country PI as per regulatory authority labelling requirements and GSK process and standards.

Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards.

Provide support to global and local GRA team members through preparation of other labelling documents as required

Complete quality and consistency checks of labelling document content.

Efficiently coordinate and manage labelling documentation and data in regulatory systems.

Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global / local roles and via Regulatory Matrix Teams.

Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff.

Support other regulatory functions and participate in other projects and activities as needed, such as contributing to the implementation of changes to labelling processes and evaluation of new agency labelling requirements.

For some roles, may be required to perform translation of labelling text into identified languages.

May become a Subject Matter Expert in country / regional labelling content and process.