Job Description

Site Name: Bengaluru Luxor North Tower
Posted Date: Aug 29 2022
Is there any greater challenge than getting ahead of disease? 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

• Timely maintenance of Global and regional/country Product Information (PI), including information for healthcare professionals and patients. Provides expertise and support to LOCs with respect to Global PI processes and responses to Regulatory Agency questions about PI.

Key Responsibilities

• Efficient management of updates to Global PI including leading the functional experts to generate content, authoring identified sections of the Global PI, presentation of items at Global Labelling Committee, and ensuring compliance with associated timelines.
• Efficient maintenance of country/regional labelling in compliance with GSK Labelling processes and external requirements such as management of the International PI document, US PI and EU PI (for Centralised, Mutual Recognition and Decentralised procedure submissions)
• Act as subject matter expert in GSK Global Labelling process and/or US/EU product information requirements.
• Support the LOCs in the implementation of Global PI text into country PI.
• Author responses to Regulatory Agency questions about PI.
• Authoring documentation to support the Global Labelling Committee Secretariat, as required.
• Effective planning, prioritization, communication and delivery of quality labelling documents according to company timelines and submission requirements.
• Train/coach others, as required.
• Participation in other projects and activities, such as leading implementation of changes to labelling processes.
• Proactively identify areas for improvements/efficiencies in existing labelling processes
• Mentoring / deliver training to other junior members in the labelling team

Knowledge/ Education / Previous Experience Required:- 1. Minimum Level of Education - Master’s degree in Science or Life Sciences or equivalent work experience within Regulatory Affairs in the Drug development environment Preferred Level of Education - PhD Area of Specialization - Life Sciences or Pharmacology C. Other Job-Related Skills/Background :- English language skills Knowledge of drug development and manufacturing and supply processes. Knowledge of worldwide regulatory requirements. Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager. Job-Related Experience Required :-

• >7 years relevant experience (in pharmaceutical industry or regulatory).
• Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research or regulatory).
• Attention to detail, excellent organization and time management skills.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to think flexibly in order to meet constantly shifting priorities and timelines and to independently provide solutions to issues.
• Well-developed understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
• Well-developed understanding of labelling (e.g. significant experience in managing local labelling documents/submissions and/or management of global labelling documents).

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.

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  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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