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
You will lead regulatory CMC activities for Vx products in India. You will manage post-approval variations, site and supply changes, and responses to health authority questions. You will work closely with quality, manufacturing, supply and global regulatory colleagues. We value explicit communication, attention to detail and collaborative problem solving.
This role offers growth, visible impact on patient access, and the chance to unite science, technology and talent to get ahead of disease together.
Responsibilities
- Independently and confidently executes agreed dossier strategy.
- Independently manages multiple project simultaneously; assignments will range in complexity but more complex work is expected.
- 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.
- Serves as dossier reviewer for peers and identifies improvement opportunities for Regulatory processes, policies and systems.
- Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications. May provide con
📌 Senior Regulatory Specialist (Bengaluru)
🏢 GSK
📍 Bengaluru