Senior Manager

09 ott - Siena
Gsk

Questa posizione è in GSK

Il processo di selezione sarà interamente gestito GSK.

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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 global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for biopharmaceutical development projects. You will work in cross-functional teams to prepare regulatory submissions, advise on manufacturing and quality risks,



and support interactions with regulators. We value clear thinkers who build trusting relationships, move work forward with purpose, and help their teams grow. This role offers stretch, visible impact and the chance to help GSK unite science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Lead development and implementation of global CMC regulatory strategies from early development through early lifecycle activities.
- Author, review and deliver CMC content for regulatory submissions and responses that meet global requirements.
- Identify CMC regulatory risks and present clear, practical mitigation plans to project teams and senior leaders.
- Collaborate across regulatory, quality, manufacturing, development and external partners to enable timely submissions and supply continuity

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