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Senior Regulatory Specialist Country Labelling
7 dni temu
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. Our success absolutely depends on our people.
Salary Information
We offer attractive reward packages including annual bonuses and awards for outstanding performance. Flexible working solutions are also available.
Job Description
The Senior Regulatory Specialist, Country Labelling is responsible for effective coordination, communication and maintenance of regional/country labelling documents (for multiple markets/regions) and data in regulatory systems in accordance with defined standards and processes. This role will provide support to GRA Labelling colleagues, Regulatory Matrix Teams and Local Operating companies to ensure timely update, management and communication of quality regional and local labelling/Product Information (PI) and supporting documentation required for local submissions.
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 leading the design and 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.
Subject Matter Expert
This role will serve as a Subject Matter Expert in country/regional labelling content and process for markets with complex labelling requirements. Key responsibilities include providing coaching, mentoring and knowledge sharing within GSK Labelling skill group, completing quality checks for colleagues' outputs and effectively managing interactions with Senior Stakeholders. Additionally, this role will take accountability for the management of labelling deliverables for country/region, including delivery of high-quality outputs to timelines.
