Regulatory Specialist III, Country Labelling

• 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.  

• Regulatory document management experience (particularly experience of working with and amending Product Information/Labelling Documents).
• Experience and familiarity of working within regulatory systems and communication tools.
• Some experience of managing local and global labelling documents and submissions.
• Experience of communicating with regulatory agencies.
• Experience of EU (including Linguistic review) and US label content and requirements.
• Experience of XML Labelling.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

  
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