Reg Submission Lead Iii, Sde Bengaluru (India)

Reg Submission Lead Iii, Sde Bengaluru (India)

07 Oct
|
GSK
|
India

07 Oct

GSK

India

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

Submission Delivery Excellence (SDE) is a Regulatory Affairs function which brings together the planning, operation and execution aspects for key regulatory deliverables such as current chemical entities, product expansion dossiers, labeling outputs, license maintenance and lifecycle management dossiers and regulatory information management.



This position will reside in the Pipeline group which is accountable for planning, production and submittal of Regulatory dossiers to GSK’s primary markets to support registration of recent medicines in line with R&D; objectives for marketed products and line extensions of regulatory licenses worldwide.

In this role, the position holder will be responsible for coordinating major and lifecycle regulatory submissions in our market expansion regions, managing and tracking project timelines, communicating with regulatory and operational staff across various functions, maintaining submission workplans and up-to-date knowledge of global regulations and guidelines to support internal stakeholders. The position holder will work closely with the GRL/Regional Rep (TG)/EU Agent/LOC (or equivalent) and functional teams to coordinate the appropriate content for specific submission packages within the Regulatory Vault system, maintain an accura

📌 Reg Submission Lead Iii, Sde Bengaluru (India)
🏢 GSK
📍 India

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