Senior Manager, CMC Regulatory Affairs, Global Rare Diseases
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In this Senior Manager CMC Regulatory Affairs role, you drive global CMC submissions for Chiesi Global Rare Diseases, shaping regulatory strategies and interactions with authorities. You work cross-functionally with CMOs and internal teams to assemble documentation, respond to questions, and ensure timely, high-quality filings. You’ll influence process improvements and maintain compliance across markets, contributing to the portfolio’s growth and patient impact. This position offers visibility across international teams and regulatory inspections, with a focus on ensuring robust quality and timely approvals.
Retribuzione / Benefits pension
private medical insurance
wellbeing programme
flexible benefits programme
annual bonus
relocation support
Responsabilità Author/review CMC sections for GRD portfolio across submissions (marketing authorizations, extensions, supplements, renewals, annual reports)
Advise cross-functional teams on regulatory CMC requirements
Collaborate with CMOs and teams to obtain CMC documentation for submissions
Develop regulatory strategies aligned with GRD RA CMC leadership
Prepare responses to CMC regulatory questions with SMEs
Coordinate process optimization, scale-up, and technology
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Parma, Emilia-Romagna, Italia Chiesi Group Tempo pieno 59.040 € - 73.800 € ContrattoAbout 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 united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we...
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Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.p.A. Tempo pienoSelect how often (in days) to receive an alert:Di seguito, troverà un'analisi completa di tutti i requisiti per i potenziali candidati e le istruzioni su come candidarsi. In bocca al lupo!Senior Manager, CMC Regulatory Affairs, Global Rare DiseasesDate: 1 Oct 2026Department: GRD Regulatory AffairsBusiness Area: R&D, Pharmacovigilance & Regulatory AffairsJob...
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parma, emilia romagna, Italia Biotecnologie - Farmacia - Chimica Tempo pienoSelect how often (in days) to receive an alert:Senior Manager, CMC Regulatory Affairs, Global Rare Diseases Date: 1 Oct 2026Department: GRD Regulatory AffairsBusiness Area: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma or Chiesi Affiliates in , ITAbout usChiesi is an international...
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Parma, Emilia-Romagna, Italia Chiesi Tempo pienoOverview In this Senior Manager CMC Regulatory Affairs role, you drive global CMC submissions for Chiesi Global Rare Diseases, shaping regulatory strategies and interactions with authorities. You work cross-functionally with CMOs and internal teams to assemble documentation, respond to questions, and ensure timely, high-quality filings. You’ll influence...
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Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.p.A. Tempo pienoSelect how often (in days) to receive an alert:Senior Manager, CMC Regulatory Affairs, Global Rare DiseasesDate: 1 Oct 2026Department: GRD Regulatory AffairsBusiness Area: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma or Chiesi Affiliates in , ITAbout usChiesi is an international research-focused...
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Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.p.A. Tempo pienoChiesi Farmaceutici S.p.A.Scorra verso il basso per una panoramica completa dei requisiti di questo lavoro. È la persona giusta per questa opportunità?seeks an experienced Senior Manager, CMC Regulatory Affairs for its Global Rare Diseases portfolio.The role focuses on post-approval CMC activities, coordinating with global teams and CMOs to ensure...
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parma, emilia romagna, Italia Biotecnologie - Farmacia - Chimica Tempo pienoChiesi Farmaceutici S.p.A. seeks an experienced Senior Manager, CMC Regulatory Affairs for its Global Rare Diseases portfolio. The role focuses on post-approval CMC activities, coordinating with global teams and CMOs to ensure high-quality submissions.You will shape regulatory strategies across development and marketed products, maintain timelines, and drive...
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Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.p.A. Tempo pienoChiesi Farmaceutici S.p.A. seeks an experienced Senior Manager, CMC Regulatory Affairs for its Global Rare Diseases portfolio. The role focuses on post-approval CMC activities, coordinating with global teams and CMOs to ensure high-quality submissions.You will shape regulatory strategies across development and marketed products, maintain timelines, and drive...
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Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.p.A. Tempo pienoChiesi Farmaceutici S.p.A. seeks an experienced Senior Manager, CMC Regulatory Affairs for its Global Rare Diseases portfolio. The role focuses on post-approval CMC activities, coordinating with global teams and CMOs to ensure high-quality submissions.You will shape regulatory strategies across development and marketed products, maintain timelines, and drive...
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parma, emilia romagna, Italia Chiesi Group Tempo pienoQuesta posizione è in Chiesi GroupRiassunto dell'opportunità da parte della Joinrs AI: Chiesi Group ricerca un Principal Regulatory Writer con laurea in scienze della vita o affini per gestire e sviluppare documenti regolatori in ambito farmaceutico per malattie rare. Il candidato contribuirà a sottomissioni globali collaborando con team...
