Manager, GRA CMC Vx Mature Product Siena
Site Name: Italy - Siena, Belgium-Wavre, Poznan Business Garden
Posted Date: Aug 8 2023
Manager, GRA CMC Vx Mature Product
Job Purpose:
Responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products.
Key Responsibilities:
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 to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications.
Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
Why you?
Basic Qualifications & Skills:
BSc in Life sciences or related scientific discipline
Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation in late phase
site Name: Italy, siena, Belgium-Wavre, Poznan Business Garden, responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards, understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications
Posizione di lavoro: product manager
