Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

pSelect how often (in days) to receive an alert: /ph3Senior Manager, CMC Regulatory Affairs, Global Rare Diseases /h3pDate: 1 Oct 2026 /ppDepartment: GRD Regulatory Affairs /ppBusiness Area: RD, Pharmacovigilance Regulatory Affairs /ppJob Type: Direct Employee /ppContract Type: Permanent /ppLocation: Parma or Chiesi Affiliates in, IT /ppbAbout us /b /ppChiesi 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. /ppAt 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 Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /ppDiversity 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. /ppbChiesi Global Rare Diseases /b /ppChiesi 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. /ppThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. /ppRare 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. /ppbWhat we are looking for /b /ph3bThis is what you will do /b /h3pWe are seeking a Senior Manager, CMC Regulatory Affairs, with direct experience in post-approval CMC activities to support Chiesi’s Global Rare Diseases (GRD) portfolio of commercial products worldwide. /ph3bYou will be responsible for /b /h3ulliAuthor and/or review CMC sections for the assigned GRD portfolio, including new marketing authorization applications, extension applications, investigational applications, post-approval variations and supplements, renewals, and annual reports, ensuring timely, high-quality global submissions /liliIn alignment with the GRD RA CMC Senior Director and/or Lead, advise multidisciplinary project teams on regulatory agency requirements and expectations for the CMC sections of submission dossiers /liliCollaborate with external contract manufacturing organizations (CMOs) and relevant functional teams to obtain the CMC documentation required to support regulatory submissions /liliSupport the development of regulatory strategies for assigned projects, in alignment with the GRD RA CMC Senior Director and Lead, including both products in development and marketed GRD products /liliPrepare timely responses to CMC regulatory questions in coordination with cross-functional teams and subject matter experts (SMEs), as needed /liliWork collaboratively with external CMOs and cross-functional teams on process optimization, scale-up, and technology transfer activities /liliReview and assess change control requests related to the CMC aspects of GRD products and coordinate the associated filing strategies /liliSupport the creation and maintenance of CMC submission templates /liliMaintain submission information in accordance with the company’s document management system and independently track regulatory CMC commitments and timelines for assigned projects, products, and markets /liliContribute to process development and to the preparation of standard operating procedures and work instructions for the RA CMC team, as needed /liliWith the agreement of the GRD RA CMC Lead, represent GRD RA during regulatory agency GMP inspections /liliMaintain current knowledge of applicable regulations, policies, and guidelines, and remain informed of evolving global CMC regulatory requirements /li /ulh3bYou will need to have /b /h3ulliBachelor’s degree in a scientific or technical discipline required; an advanced degree is preferred /liliMinimum of six years of regulatory CMC experience supporting small‑molecule, herbal medicinal and/or biological products /liliAdvanced knowledge of current global CMC regulations and guidelines, including ICH requirements and applicable regulatory requirements in the United States, European Union, and Canada /liliDemonstrated experience authoring technical documentation and CTD Modules 2 and 3, and managing the lifecycle o