Senior Regulatory Affairs, CMC

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, delivering...

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, delivering...

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...

Select how often (in days) to receive an alert:Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.Over three years ago, we embarked on a transformative journey to...

RequisitiISO/IEC 27001, ISO/IEC 42001.L'innovazione sanitaria deve arrivare ai pazienti, non fermarsi al regolamento.Ardeevo affianca i fabbricanti di dispositivi medici e di dispositivi medico-diagnostici in vitro nel percorso di conformità al Regolamento (UE) 2017/745 (MDR) e al Regolamento (UE) 2017/746 (IVDR), con servizi di Regulatory Affairs e Quality...

Ardeevo cerca professionisti per rafforzare il nucleo regolatorio e QA nel contesto MDR/IVDR. Revisionerete output regolatori generati da una piattaforma AI-Native, fornendo verdetti motivati e miglioramenti di processo.La posizione prevede supporto ai clienti, collaborazione con il team prodotto e contatto con Organismo Notificato. Si valuta esperienza su...

OverviewQuality 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 achieveAs a QARA Specialist you will ensure compliance with Quality and Regulatory standards across the company, contributing to better...

Select how often (in days) to receive an alert: Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy....

Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are...