Director, Regulatory Affairs EU

The Director, Regulatory Affairs — Europe (the “EU RA Lead”) will own the Company’s European regulatory strategy and execution and will lead the Marketing Authorization Application (MAA) for SC VK2735 under the centralized procedure, followed by the corresponding application for oral VK2735. The role carries end-to-end responsibility for the MAA: eligibility and Rapporteur engagement, pre-submission activity, dossier assembly and validation, management of the assessment clock and responses to CHMP questions, oral explanation preparation, labelling negotiation through CHMP opinion and European Commission decision, and pricing and reimbursement. The role also owns the United Kingdom strategy and submission to the MHRA and interactions with the HPRA in Ireland.

The Vice President of Regulatory Affairs retains overall accountability for global, program-level regulatory strategy. Within that framework, the EU RA Lead holds decision authority for European regulatory positions and is expected to execute the resulting work directly. This is a working role within a lean, virtual-sponsor operating model: the successful candidate will be comfortable authoring and quality-controlling submission content personally while simultaneously directing consultants and vendors.