Senior Regulatory

Ricerca di un Regulatory Affairs Specialist Senior per un'azienda farmaceutica internazionale. La risorsa gestirà le attività regolatorie per il mercato italiano,

Sentinel Diagnostics, leader in the Development and Production of Diagnostic Kits for Clinical Chemistry, Immunology, Molecular Biology, Chromatography and Rapid Tests, in order to expand the RA Team, is looking for a: Senior Regulatory Affairs Specialist FDA & International Registrations Key Responsibilities * Define and implement regulatory strategies to...

Overview In this role you will lead labeling strategy within Global Regulatory Affairs to align CCDS, dCCDS, USPI and EU SmPC across products. You will influence product development plans, ensure compliant labeling and support commercial opportunities. You’ll collaborate with GRA, GCD, GCSP and cross-functional teams to maintain global consistency and...

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 questa posizione, entrerai nel dipartimento Legale di Milano per supportare tematiche di diritto regolamentare e diritto bancario. L’attività è rivolta a clienti come società di gestione del risparmio e banche, con opportunità di collaborare strettamente con colleghi del network PwC. Contribuisci a progetti regolamentari e di compliance,...

Sentinel Diagnostics Group cerca uno Senior Regulatory Affairs Specialist per registrazioni FDA e mercati internazionali. La posizione è ibrida: Milano onsite e lavoro da remoto, con frequenti viaggi internazionali. Definire strategie regolatorie, gestire sottomissioni 510(k) e interfacciarsi con consulenti e FDA per supportare i team di prodotto....

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...

Overview In this role you will lead labeling strategy within Global Regulatory Affairs to align CCDS, dCCDS, USPI and EU SmPC across products. You will influence product development plans, ensure compliant labeling and support commercial opportunities. You'll collaborate with GRA, GCD, GCSP and cross-functional teams to maintain global consistency and...

Overview Quality Assurance Regulatory Affairs (QARA) Specialist – Dedalus. Remote in Italy. Part of the Global Quality and Assurance Team to drive quality and regulatory excellence in healthcare technology. What you’ll achieve As a QARA Specialist you will ensure compliance with Quality and Regulatory standards across the company, contributing to better...