Regulatory Specialist III Country Labelling
Regulatory Specialist III Country Labelling
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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.
Remote Work :
No
Employment Type
Full Time
