GSK Global Regulatory Affairs is seeking an Associate Director that can provide critical strategic and operational regulatory leadership across the Oncology portfolio of products that require the co-development and registration of a diagnostic, primarily in EU. The successful applicant will also provide medical device regulatory strategic support in the area of use digital and mobile applications as well as real world data as applicable to regulatory strategy and serve as a resource for the evaluation of stand-alone medical devices and in vitro diagnostic tests of interest to GSK. Prior experience in laboratory testing or diagnostics is highly preferred
Ensure the development of appropriate global and/or regional regulatory strategy(s) including EU and their execution for assigned asset(s) consistent with Medicines Development Strategy to ensure the development program meets the needs of the key markets identified and the Medicine Profile. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data.
Responsibilities and Accountabilities (include expected deliverables, managerial and leadership responsibilities and performance standards)
Accountable to GRL or Senior Director/Head of CDx Regulatory, for development of appropriate EU/global regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK, reviewing, contributing and editing submission dossiers, and representing GSK with the regulatory agency. Work with the MDT to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified and the Medicine Profile. Lead interactions with local / regional /global regulatory authorities. In performing the role, the job holder will be responsible for:
Competencies and Capabilities (include key high performance behaviors)
Competencies and Capabilities
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