CMC Senior Specialist
3 settimane fa
Join to apply for the CMC Senior Specialist role at Zambon Zambon is a multinational pharmaceutical and chemical company that focuses on innovation and development with the aim to improve the quality of people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its Vision is “Innovating cure and care to make patients’ lives better”. Zambon operates in the pharmaceutical and chemical business and is present in 20 countries with subsidiaries in three different Continents – Europe, America, and Asia – and over 2900 employees, with manufacturing units in Italy, Switzerland, France, China, and Brazil. Zambon products are commercialized in 84 countries. The company is working on the treatment of specialties and rare diseases, such as Parkinson’s disease and Cystic Fibrosis, and is well-established in 3 therapeutic areas: respiratory, pain, and women’s care. The Role Zambon SpA is looking for a CMC Senior Specialist that will ensure the technical support for management of product registration dossier and will write and review the Quality Part of the CTD with internal and external resources. Main Responsibilities of the role Managing of the CROs/CMOs performing all the necessary process development, manufacturing and analytical activities required for all drug substance and drug product development activities in support of new dossier submission for registration and product lifecycle in collaboration with the other internal stakeholders. Managing of the CMC regulatory strategy for the submission and during the review phase by the Health Authorities. Writing and review of protocols and reports in support of regulatory section submissions (Module 3 eCTD). Designing plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations. Writing and/or reviewing Module 3 of eCTD in collaboration with consultants as required; prepare, review CMC regulatory and Quality documents. What we are looking for Degree in Life Sciences/Health Related Sciences (CTF/Pharmacy). 5+ years of experience in Regulatory Affairs/CMC preferably in Corporate Roles. Excellent knowledge of written and spoken English. Place of Work Bresso (MI) Seniority Level Associate Employment type Full-time Job function Other and Research Industries Pharmaceutical Manufacturing #J-18808-Ljbffr
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CMC Senior Specialist
3 settimane fa
bresso, Italia Zambon A tempo pienoJoin to apply for the CMC Senior Specialist role at ZambonZambon is a multinational pharmaceutical and chemical company that focuses on innovation and development with the aim to improve the quality of people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its Vision is “Innovating cure and care to make...
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Senior CMC Regulatory Specialist | Global Pharma
3 settimane fa
Bresso, Italia Zambon A tempo pienoA multinational pharmaceutical company is seeking a CMC Senior Specialist in Bresso, Italy. The role involves managing regulatory submissions and ensuring compliance with cGMP and FDA standards. Candidates should have a degree in Life Sciences and over 5 years of Regulatory Affairs experience. Excellent English communication skills are essential. This...
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Biostatistician Sr. Specialist
2 settimane fa
Bresso, Italia Zambon A tempo pienoJoin to apply for the Biostatistician Sr. Specialist role at Zambon Zambon is a multinational pharmaceutical and chemical company focused on innovation and development to improve people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its Vision is “Innovating cure and care to make patients’ lives...
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Biostatistician Sr. Specialist
2 settimane fa
Bresso, Italia Zambon A tempo pienoJoin to apply for the Biostatistician Sr. Specialist role at Zambon Zambon is a multinational pharmaceutical and chemical company focused on innovation and development to improve people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its Vision is “Innovating cure and care to make patients’ lives...
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Biostatistician Sr. Specialist
2 settimane fa
bresso, Italia Zambon A tempo pienoJoin to apply for the Biostatistician Sr. Specialist role at ZambonZambon is a multinational pharmaceutical and chemical company focused on innovation and development to improve people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its Vision is “Innovating cure and care to make patients’ lives...
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Biostatistician Sr. Specialist
2 settimane fa
Bresso, Italia Zambon A tempo pienoJoin to apply for the Biostatistician Sr. Specialist role at ZambonZambon is a multinational pharmaceutical and chemical company focused on innovation and development to improve people’s health and patients’ lives. Based on a valuable heritage but strongly focused on the future, its Vision is “Innovating cure and care to make patients’ lives...
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Bresso, Lombardia, Italia WINclusion A tempo pienoaziendaIl nostro partner è un'azienda multinazionale, punto di riferimento nella diagnostica di laboratorio, con un focus su immunodiagnostica e diagnostica molecolare.Innovazione, qualità e affidabilità guidano lo sviluppo di soluzioni diagnostiche avanzate, supportando professionisti sanitari in oltre 100 paesi.Con una forte attenzione alla ricerca,...
