Manager, CMC Regulatory Affairs, Global Rare Diseases

Maintain or create CMC regulatory documents for dedicated products to support submissions to global regulatory authorities, managing these documents with full responsibility and no supervision. Act as the CMC representative at the core team level, authoring and reviewing CMC sections for new marketing authorization applications, investigational applications, and variations worldwide. Advise multidisciplinary project teams on regulatory agency requirements, review change control requests, and negotiate strategies with regulatory agencies on CMC submission dossiers. Represent the function during GMP inspections and support due diligence activities where required. Collaborate with external CMOs and cross-functional teams on process optimizations, scale-up, and technology transfer activities while maintaining submission information in the document management system. This role supports Chiesi Global Rare Diseases in developing treatments for lysosomal storage diseases, rare hematology, ophthalmology, and immunodeficiencies.