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. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
Job Purpose:
Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product development and consistent with the Vaccines Development Strategy/Integrated Asset Plan (IAP). This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data.
Key Responsibilities:
Accountable to the asset GRL and/or the Global Regulatory TG Head for development and delivery of appropriate regulatory strategy(ies) according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK up to VP level and representing GSK GRA in interactions with key regulatory agencies (EMA, CBER, PMDA etc). Work closely with R&D, Medical and Commercial teams to secure best possible labelling commensurate with the available data:
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