About usChiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.We believe our differences make us stronger. Chiesi Global Rare DiseasesChiesi 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.This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology,

ophthalmology disorders and rare immunodeficiencies. What we are looking forThis is what you will doWithin the Global Rare Diseases, R&D;, Regulatory Affairs and reporting to the VP, Global Regulatory Affairs, Global Rare Diseases the Principal Regulatory Writer is responsible for authoring, reviewing, and managing regulatory documents that translate clinical, nonclinical and CMC data into clear, accurate, and compliant submissions for global health authorities (e.g., FDA, EMA, MHRA, NMPA, Health Canada), supporting both initial marketing applications and post‐approval lifecycle activities for drugs and biological products.They serve as a central member of cross‐functional regulatory submission teams, working in close collaboration with Global and Regional Regulatory Leads, Clinical Development, Biostatistics, Safety/Pharmacovigilance, CMC, Medical Affairs, and external partners to ensure consistency, scientific rigor,

Principal Regulatory Writer, Global Rare Diseases

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