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Regulatory Affairs Lead

Novo Nordisk · GB

Regulatory Affairs Lead Medical & Regulatory Gatwick, UK Join our UK Regulatory team and play a central role in delivering strategically important, timely an...

Job description

Regulatory Affairs Lead Medical & Regulatory Gatwick, UK Join our UK Regulatory team and play a central role in delivering strategically important, timely and high‑quality submissions that help bring innovative medicines and devices to patients. Your new role: As Regulatory Affairs Lead you will manage, plan and execute regulatory projects within the UK Regulatory, Safety & Medical Information (RSM) team. You will provide technical and strategic support to the Associate Director of RSM and to UK Regulatory Affairs (UKRA), partner with business units to align regulatory files with business needs and lead complex submissions and lifecycle changes (including new products, line extensions and strategic projects) for the MHRA and other relevant authorities. Day‑to‑day your tasks will include: - Lead regulatory projects end‑to‑end: planning resources and budgets, providing strategic input, performing risk analysis and delivering implementation plans. - Act as UK point‑of‑contact for allocated projects, including official meetings with health authorities (e.g., Scientific Advice), and represent UKRA in Global Regulatory Portfolio Teams where required. - Compile, prepare and ensure submiss...