About the role Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
About the responsibilities Be responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities Be responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and early lifecycle management activities in accordance with the applicable regulatory 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.
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📌 Regulatory Manager, Strategy (Siena)
🏢 Gsk
📍 Siena
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