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 & scientific standards.
- Understand, interpret and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the submission,



review and approval of global CMC applications.
- Ensure all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensure information submitted in clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
- Work in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnershi

Regulatory Manager, Strategy - CMC RA Vaccines Development Projects Siena

📌 Regulatory Manager, Strategy (Toscana)
🏢 Gsk
📍 Toscana