Lead Regulatory Affairs

Overview In questa posizione, ti occupi di gestire le attività regolatorie per dispositivi medici a livello nazionale ed internazionale, garantendo conformità normativa, sottomissioni e manutenção delle registrazioni. Lavorerai a stretto contatto con sedi estere, distributori e funzioni interne per facilitare l accesso ai mercati e l introduzione di...

Overview In this role you will support worldwide post-approval regulatory activities focused on CMC for vaccines or biological products. You will work within a regulatory team to shape submission strategies, assess quality-related changes, and coordinate cross-functional input for regulatory dossiers. The position emphasizes collaboration across...

Overview As a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance. Your work supports variations, renewals, and market expansions,...

Overview In this senior regulatory role, you provide strategic legal guidance across the lifecycle of Illumina’s medical devices, diagnostics, and life-science products in EMEA and Latin America. You collaborate with cross-functional teams to enable compliant product development, submission, and post-market activities in a fast-paced, international...

ACS DOBFAR S.P.A. cerca una risorsa per l’area R&D con ruolo di supporto trasversale al Project Management e Regulatory Affairs. Verrà collegata tra R&D, Laboratorio, Regolatorio, QA e Produzione per assicurare flussi informativi, tracciabilità e aggiornamenti sui progetti.La risorsa supporterà le attività regolatorie e la predisposizione della...

Overview Senior Site Contracts Lead to guide site contract lifecycle across studies, ensuring compliant negotiations and templates. You will coordinate with country experts, sponsors, and the Contracts Department to manage NDAs, CTAs, amendments, and related documents. The role focuses on risk mitigation, timeline control, and regulatory alignment to enable...

Chiesi seeks a Senior Global Patient Safety Physician to lead safety science for assigned products and shape proactive risk management and surveillance. You will collaborate across Clinical Development, Medical Affairs, Regulatory, and Quality to integrate safety data into development plans and submissions, driving data-driven safety evaluations throughout...

Overview You will lead the governance of lifecycle management for Chiesi’s Air/Care and Rare products, partnering with R&D, regulatory, manufacturing and quality teams to drive proactive lifecycle practices. This role anchors governance documentation and ensures regulatory compliance across global markets, while enabling cross-functional collaboration and...

Chiesi in Sardegna is seeking a Clinical Innovation Project Manager to lead end-to-end RWE and evidence generation across geographies. You will translate strategies into actionable plans, ensure quality, compliance, and timely delivery, and collaborate with Global Clinical Development and Medical Affairs.You will manage study design input, budget, timelines,...