Date: 10 Feb 2026\nDepartment: GRD Regulatory Affairs\nBusiness Area: R&D;, Pharmacovigilance & Regulatory Affairs\nJob Type: Direct Employee\nContract Type: Permanent\nLocation: Europe, IT\nSenior Manager, CMC Regulatory Affairs, Global Rare Diseases\nAbout us\nChiesi 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 research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.\nAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.\nDiversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.\nChiesi Global Rare Diseases\nChiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.\nThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.\nRare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here .\nWhat we are looking for\nThis is what you will do\nCurrently seeking a Regulatory Affairs (RA) Senior Manager with strong CMC pre and post approval experience to support Chiesi’s Global Rare Diseases (GRD) global portfolio of commercial products\nYou will be responsible for Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities, according to the GRDRA strategy\nManage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team and GCST, with full responsibility and no need of supervision\nAct as the GRDRA CMC representative at core team level with a global role, where required\nAuthor and/or review CMC sections of the dedicated GRD portfolio for new marketing authorisation applications, investigational applications and variations/supplements, worldwide\nAdvise to multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier\nReview and assess change control requests pertaining to CMC aspects of GRD product(s)\nIn alignment with GRDRA CMC functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy for the GRD products life cycle and development\nMaintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision.\nWork collaboratively with external CMOs and cross-functional teams on projects like process optimizations, scale up and technology transfer activities.\nIn agreement with GRDRA CMC functions and collaborating with GRDRA region functions, negotiate with regulatory agencies strategies and actions on CMC sections of submission dossier\nSupport the development of processes and to the preparation of Standard Operating Procedures where required.\nSupport due diligence activities on CMC regulatory documents, where required\nRepresent GRDRA during GMP inspections by regulatory agencies, where required\nMaintain sound knowledge of regulations, policies/guidelines, and keep abreast with current and evolving regulatory CMC requirements. You will need to have Minimum of a bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree strongly preferred.\n7 + years of Regulatory CMC experience; 3 + years experience in Biologics/Biopharmaceuticals (candidates without Biologics experience will not be considered)\nAdvanced knowledge of current global CMC regulations, including ICH requirements and US/EU regulatory requirements.\nSound knowledge of manufacturing technical transfer and comparability regulatory requirements\nExperience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations.\nProficient in the use of quality management software (e.g. TrackWise) and regulatory document information management syste We would prefer for you to have Strong attention to detail.\nAbi