Project Manager, CMC Regulatory Affairs

Job description

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 Project Manager, CMC Regulatory Affairs Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products. Key Responsibilities include, but are not limited to: Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities. Responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions (IND/IMP...