Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

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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. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. What we are looking forThis is what you will doCurrently 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 productsYou will be responsible forMaintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities, according to the GRDRA strategyManage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team and GCST, with full responsibility and no need of supervisionAct as the GRDRA CMC representative at core team level with a global role, where requiredAuthor and/or review CMC sections of the dedicated GRD portfolio for new marke

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dtyd3