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Lead EU pre‑approval regulatory strategy and documentation requirements. Own end‑to‑end dossiers for DCP/MRP/National submissions, ensuring quality and on‑time delivery. Act as primary liaison with EU Regulatory Authorities; coordinate responses
Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements. Under general supervision, implement product related
Provide scientific interpretation of preclinical ophthalmology data including in vivo models to assess proof of concept. Translate nonclinical findings into regulatory and early clinical development recommendations. Define and guide the overall regulatory
In this role, you will lead the development and execution of global clinical-regulatory strategies for Novocure’s Class IIb/III medical device portfolio, supporting programs from early clinical development through commercialization and lifecycle
In this role you will be responsible for ensuring strategies and relationships with local authorities align with the business needs of Perrigo Europe North Cluster with a particular focus on UK & Ireland. Ensure company’s regulatory affairs