Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Aug 29 2022
Ready to help shape the future of healthcare? 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Job Purpose:- The Job Holder provides support to GRA Labelling staff, Regulatory Matrix Teams and Local Operating Companies to ensure the timely update, management and communication of quality regional/country Product Information (PI)/labelling and supporting documentation. The Job Holder ensures effective coordination, communication and maintenance of regional/country labelling documents and data in regulatory systems in accordance with defined standards and processes. 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 in country/regional labelling content and process for markets with complex labelling requirements:
  • provides coaching, mentoring and knowledge sharing within GSK Labelling skill group
  • completes quality checks for colleagues’ outputs
  • effectively manages interactions with Senior Stakeholders
  • takes accountability for the management of labelling deliverables for country/region, including delivery of high-quality outputs to timelines
  • may represent GSK externally

Knowledge/Education Required:- Minimum Level of Education Required - Bachelor’s degree in Science or Life Sciences or equivalent work experience within Regulatory Affairs in the Drug development environment Preferred Level of Education - Master’s degree, PhD Area of Specialization - Life Sciences Previous Experience Required:- Minimum Level of Job-Related Experience Required -

• >7 years relevant experience (in pharmaceutical industry, life sciences research or regulatory).
• Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research, pharmacy, safety or regulatory).
• Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple projects for different customers.
• Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.
• Broad understanding of the pharmaceutical industry, drug development environment, development and established product lifecycle maintenance and regulatory processes.
• Knowledge and understanding of product labelling (e.g. through direct exposure to the management of labelling documents/submissions/data; including label authoring).
• Experience of maintenance of labelling documents in multiple countries/regions including knowledge of label document content, process and associated regulatory agency labelling requirements. Experience of more than 1 of the following regions/countries:
  • EU PI annexes (including EU CP/MRP/DCP procedures)
  • US PIs
  • Canadian Monographs
  • ROW PIs
• Experience in authoring and/or updating Labelling SOPs, WIs, QRGs by identifying areas for efficiencies in existing Labelling processes
• Proficient with computer software applications
• Familiarity with medical terminology required
• Ability to lead problem solving and negotiate solutions to complex labeling issues

Job-Related Experience sections above that are required for the job:-

• 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.
• Proven experience in defining strategy and ensuring delivery of Regional/Country labelling components throughout product lifecycle, product development and launch into markets.
• Experience in supporting regional labelling leads in development/update of labelling content to be applied further to printed packaging components.
• Experience in a variety of Regional Labeling activities with minimal input from function manager.
• Detailed understanding of EU, US and rest of world label content, regulations and requirements.
• Subject matter expert in associated Labelling processes.
• Experience of labelling for pharmaceutical and vaccine products

At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

• LI-GSK

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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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