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 Specialist is responsible for 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 be supporting Global Regulatory teams in the preparation of regulatory dossiers for R&D and Commercial projects, ensuring submissions are delivered within agreed timelines and in compliance with GSK policies and processes.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include some of the following:
Under management oversight, responsible for delivering assigned submissions in line with the 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.
Simultaneously, follow-up for multiple project assignments, including Variations (CMC and Therapeutic), PBRER, Renewals, Site Registrations/Site Renewals, Tenders of varying complexity.
Manage regulatory registration requirements, including those requested directly from regulatory agencies, manufacturing sites or third-party service providers. This includes providing manufacturing site support to meet regulatory expectations.
Prepare, coordinate and ensure timely delivery of documents requested from health authorities, legalization providers, manufacturing sites or third parties.
Accountable for adhering to GSK ways of working, processes and written standards, while building a thorough understanding to ensure right first-time delivery. Leverages regulatory intelligence resources to determine Regulatory registration requirements, ensuring they are fit for purpose for assigned submissions as needed, and proactively identifies risks associated with submission data and information packages.
Keep regular communication with the line manager, technical lead, functional teams and LOCs (or equivalent), and, where applicable, with health authorities and external stakeholders (certificates and samples). Implements the agreed dossier strategy for assigned deliverables and escalates any issues that could affect the business, such as unavailable deliverables or changes in local requirements.
Ensures the quality and compliance of both personal and team submissions with regulatory guidelines and processes, under management oversight. May review peers deliverables and propose improvements to regulatory processes, policies, and systems thereby driving efficiency & innovation.
Develops expertise in regulations, guidelines, procedures, and policies governing pharmaceutical product registration and manufacturing to facilitate efficient submission, review, and approval of global regulatory applications. Demonstrates adaptability and learning agility to navigate internal and external regulatory landscapes.
Demonstrates strong collaboration skills and the ability to build effective organizational networks, actively fostering and expanding connections within the organization.
Communicate effectively with internal and external GSK stakeholders on project- and policy-related matters with minimal managerial supervision, ensuring the best outcomes for the organization.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field.
1-3 years of relevant experience.
Basic understanding of the pharmaceutical industry, drug development processes, manufacturing, supply and R&D objectives.
Knowledge of EU and ROW regulations, guidelines, procedures, and policies for the registration and manufacturing of pharmaceutical and vaccine products. Ability to interpret and provide advice on submission guidelines and requirements, utilizing recent GSK experience.
Proficiency in using Veeva Vault systems or the ability to quickly learn and adapt to required technical skills.
Excellent organizational skills, meticulous attention to detail, and a strong commitment to producing high-quality work, even in challenging regulatory deadline environments. Proven capability to manage workloads, prioritize effectively, adapt to shifting demands, and oversee multiple projects simultaneously.
Working Model
This role is on-site in India with occasional hybrid flexibility subject to business needs. You will work with colleagues across time zones and with global partners.
What we value
We look for people who focus on quality and patient impact, act with transparency and respect, and work collaboratively. You will join a supportive team that encourages learning, ownership, and continuous improvement.
We encourage you to apply
If this role matches your skills and career goals, we want to hear from you. Tell us how you can contribute and what you want to learn next. If you need adjustments during the recruitment process, please let us know so we can support you. Apply now to help move important regulatory work forward.
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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