Senior manager, cmc regulatory affairs, global rare diseases

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Senior Manager, CMC Regulatory Affairs, Global Rare Diseases Department: GRD Regulatory Affairs Business Area: R&D;, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT (role can be based in one of our affiliates in Europe) Chiesi is an international research‐focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries. Our headquarters are 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. About the role The Senior Manager, CMC Regulatory Affairs will support Chiesi's Global Rare Diseases (GRD) portfolio of commercial products with strong CMC pre and post approval experience. Responsibilities 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 Manage 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 Act as the GRDRA CMC representative at core team level with a global role, where required Author and/or review CMC sections of the dedicated GRD portfolio for new marketing authorisation applications, investigational applications and variations/supplements, worldwide Advise multidisciplinary project teams on regulatory agency requirements and expectations on CMC sections of submission dossier Review and assess change control requests pertaining to CMC aspects of GRD product(s) In 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 Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets with minimal supervision Work colla

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