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

• Represents CMC Delivery team on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing Organizations and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers.




• Role requires a general understanding of submission requirements for multiple countries/ submission types and an ability to work in a matrix setting.
Responsible for timely delivery of regulatory activities of multiple Vx projects across dosage forms
• Will serve as a mentor/trainer for new team members.
• May act as a Subject Matter Expert for specific areas for consultation within
the team/ department as well as externally outside the department.

Responsibilities

• Independently manages multiple Vx CMC regulatory submission assignments simultaneously; assignments will range in complexity, but more complex work is expected.
• Independently and confidently executes agreed dossier strategy.
• Independently completes data assessment to ensure dossier is fit for purpose.
• Identifies risks associated with submission data and information packages.
• Escalates issues with line manager that have business impact.
• May act as reviewer/approver for dossie

📌 Senior Regulatory Specialist (Bengaluru)
🏢 GSK
📍 Bengaluru