Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
This is an exciting opportunity to play a key role in supporting global regulatory labelling activities. You will collaborate with cross-functional teams to ensure timely and compliant labelling submissions that align with regulatory requirements. We are looking for a detail-oriented and proactive individual who is passionate about making a meaningful impact on global healthcare. Join us to grow your career while contributing to GSK’s mission of uniting science, technology, and talent to get ahead of disease together.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Maintain/Update the Company Core Datasheet / Global Datasheet (CCDS/GDS) in conjunction with functional experts.
Maintain/Update the EU PI (CP/MRP/DCP), International Product Information (IPI), Vaccine WHO and PAHO PI and Medical Device product labels. Ensure compliance with global PI and submit country labelling deviations if any.
Manage the Product Information for products in conjunction with a third party.
Coordinate the readability testing of the EU Package Leaflet when applicable.
Lead the discussion at Labelling Review Team (LRT) around the proposed wording for the CCDS/GDS and centrally managed PIs (when applicable) and seek agreement with all stakeholders involved.
Author and coordinate the supportive packages for submission to the Global Labelling Committee (GLC). Author GLC meeting minutes (if applicable).
Support the Local Operating Companies (LOC):
in the implementation of Global PI text into country PI.
in authoring and coordinating responses to labelling questions from regulatory agencies.
in evaluating LOC submission delay request and facilitating its approval if required.
Take accountability for relevant labelling sections of the periodic aggregate reports like PBRER, ACO, Addendum Reports, DSUR, etc.
Member of the Regulatory Matrix Team (RMT) and the Safety Review Team (SRT) as appropriate.
May represent Global Labelling in Product Investigation Review Committee (PIRC) and internal audits.
May represent GSK Global Labelling in
inspections or meetings with regulatory authorities.
external events (conferences/seminars, etc.).
Train/coach others in future, as required
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Master's degree in Life Sciences, Pharmacy, Dental or Medical.
>7 years relevant experience (in labelling or regulatory affairs).
Understanding of the pharmaceutical industry, drug development environment and regulatory processes.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Experience in an international regulatory environment.
Knowledge of digital tools and platforms, such as Veeva Vault.
Familiarity with regulatory lifecycle management processes.
Ability to work collaboratively in a matrix environment.
Proactive problem-solving skills and ability to adapt to changing priorities.
Work Arrangement
This role is based in Bangalore and follows a hybrid working model, combining remote and on-site work.
We are looking for individuals who are passionate about making a difference and thrive in a collaborative, fast-paced environment. If this sounds like you, we encourage you to apply!
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
This is an exciting opportunity to play a key role in supporting global regulatory labelling activities. You will collaborate with cross-functional teams to ensure timely and compliant labelling submissions that align with regulatory requirements. We are looking for a detail-oriented and proactive individual who is passionate about making a meaningful impact on global healthcare. Join us to grow your career while contributing to GSK’s mission of uniting science, technology, and talent to get ahead of disease together.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Maintain/Update the Company Core Datasheet / Global Datasheet (CCDS/GDS) in conjunction with functional experts.
Maintain/Update the EU PI (CP/MRP/DCP), International Product Information (IPI), Vaccine WHO and PAHO PI and Medical Device product labels. Ensure compliance with global PI and submit country labelling deviations if any.
Manage the Product Information for products in conjunction with a third party.
Coordinate the readability testing of the EU Package Leaflet when applicable.
Lead the discussion at Labelling Review Team (LRT) around the proposed wording for the CCDS/GDS and centrally managed PIs (when applicable) and seek agreement with all stakeholders involved.
Author and coordinate the supportive packages for submission to the Global Labelling Committee (GLC). Author GLC meeting minutes (if applicable).
Support the Local Operating Companies (LOC):
in the implementation of Global PI text into country PI.
in authoring and coordinating responses to labelling questions from regulatory agencies.
in evaluating LOC submission delay request and facilitating its approval if required.
Take accountability for relevant labelling sections of the periodic aggregate reports like PBRER, ACO, Addendum Reports, DSUR, etc.
Member of the Regulatory Matrix Team (RMT) and the Safety Review Team (SRT) as appropriate.
May represent Global Labelling in Product Investigation Review Committee (PIRC) and internal audits.
May represent GSK Global Labelling in
inspections or meetings with regulatory authorities.
external events (conferences/seminars, etc.).
Train/coach others in future, as required
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Master's degree in Life Sciences, Pharmacy, Dental or Medical.
>7 years relevant experience (in labelling or regulatory affairs).
Understanding of the pharmaceutical industry, drug development environment and regulatory processes.
Preferred Qualification
If you have the following characteristics, it would be a plus:
Experience in an international regulatory environment.
Knowledge of digital tools and platforms, such as Veeva Vault.
Familiarity with regulatory lifecycle management processes.
Ability to work collaboratively in a matrix environment.
Proactive problem-solving skills and ability to adapt to changing priorities.
Work Arrangement
This role is based in Bangalore and follows a hybrid working model, combining remote and on-site work.
We are looking for individuals who are passionate about making a difference and thrive in a collaborative, fast-paced environment. If this sounds like you, we encourage you to apply!
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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