Senior Manager, CMC Regulatory Affairs, Global Rare Diseases

About us
Chiesi 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.

At 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. Diversity 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.

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. Discover more here.

What we are looking forThis is what you will doWe 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.

You will be responsible forAuthor 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 submissionsIn 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 dossiersCollaborate with external contract manufacturing organizations (CMOs) and relevant functional teams to obtain the CMC documentation required to support regulatory submissionsSupport 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 productsPrepare timely responses to CMC regulatory questions in coordination with cross-functional teams and subject matter experts (SMEs), as neededWork collaboratively with external CMOs and cross-functional teams on process optimization, scale-up, and technology transfer activitiesReview and assess change control requests related to the CMC aspects of GRD products and coordinate the associated filing strategiesSupport the creation and maintenance of CMC submission templatesMaintain submission information in accordance with the company's document management system and independently track regulatory CMC commitments and timelines for assigned projects, products, and marketsContribute to process development and to the preparation of standard operating procedures and work instructions for the RA CMC team, as neededWith the agreement of the GRD RA CMC Lead, represent GRD RA during regulatory agency GMP inspectionsMaintain current knowledge of applicable regulations, policies, and guidelines, and remain informed of evolving global CMC regulatory requirementsYou will need to haveBachelor's degree in a scientific or technical discipline required; an advanced degree is preferredMinimum of six years of regulatory CMC experience supporting small-molecule, herbal medicinal and/or biological productsAdvanced knowledge of current global CMC regulations and guidelines, including ICH requirements and applicable regulatory requirements in the United States, European Union, and CanadaDemonstrated experience authoring technical documentation and CTD Modules 2 and 3, and managing the lifecycle of quality-related post-approval changes across international markets ex-US and ex-EuropeExperience with quality management systems, such as TrackWise, and regulatory information and document management platforms, such as Veeva RIM, is considered an assetExceptional attention to detail and a strong commitment to quality and accuracyDemonstrated ability to manage competing priorities, maintain strong organization, and consistently meet deadlinesExcellent written, verbal, and interper