CMC Senior Specialist

ppJoin to apply for the CMC Senior Specialist role at Zambon /p pZambon 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. /p h3The Role /h3 pbZambon SpA /b is looking for a bCMC Senior Specialist /b 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. /p h3Main Responsibilities of the role /h3 ul liManaging 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. /li liManaging of the CMC regulatory strategy for the submission and during the review phase by the Health Authorities. /li liWriting and review of protocols and reports in support of regulatory section submissions (Module 3 eCTD). /li liDesigning plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations. /li liWriting and/or reviewing Module 3 of eCTD in collaboration with consultants as required; prepare, review CMC regulatory and Quality documents. /li /ul h3What we are looking for /h3 ul liDegree in Life Sciences/Health Related Sciences (CTF/Pharmacy). /li li5+ years of experience in Regulatory Affairs/CMC preferably in Corporate Roles. /li liExcellent knowledge of written and spoken English. /li /ul h3Place of Work /h3 pBresso (MI) /p h3Seniority Level /h3 ulliAssociate /li /ul h3Employment type /h3 ulliFull-time /li /ul h3Job function /h3 ulliOther and Research /li /ul h3Industries /h3 ulliPharmaceutical Manufacturing /li /ul /p #J-18808-Ljbffr