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
The Regulatory Submission Lead is responsible for independently supporting regulatory submission activities, including authoring, reviewing, providing Regulatory registration requirements and compiling dossiers for assigned deliverables in compliance with health authority regulations and GSK policies and processes. The position holder works with the Submission teams,



Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent) to coordinate and prepare submission packages within the Veeva Vault system.
The position holder will also include mentoring and training current team members.

Responsibilities
Responsible for independently delivering assigned submissions as per agreed dossier strategy to the Submission teams, Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent), by working collaboratively with functional teams (e.g., CMC, Clinical, Nonclinical, etc.) ensuring adherence to established timelines in assigned markets.
Simultaneously oversees, multiple project assignments, including Variations (CMC and Therapeutic), PBRER, Renewals, Site Registrations/Site Renewals, Tenders of more complexity.
Manage complex regulatory registration requirements, including those requested directly from

📌 Reg Submission Lead, SDE- LCM (Bengaluru)
🏢 GSK
📍 Bengaluru