Associate Director Regulatory Affairs, OncologyAt 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 revolutionizing the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.This role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines 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.Accountable to GRL and Global Regulatory TA Head for development of appropriate regional 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 to VP level and representing GSK with at least the local regulatory agency. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile. Work closely with local / regional commercial team to secure best possible labeling commensurate with the available data. Lead interactions with local / regional regulatory authorities.Key Responsibilities:Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking into
Associate Director Regulatory Affairs, Oncology in Bath employer: GSK
GSK is an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the heart of Stevenage. With a strong commitment to employee growth, you will have access to extensive development opportunities while working on groundbreaking medicine projects. The hybrid work model and future relocation to Cambridge provide a unique advantage, ensuring a vibrant environment for both personal and professional advancement.
