Chiesi 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 Benefit 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 Diseases Chiesi 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. Currently 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 products 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 Author and/or review CMC sections of the dedicated GRD portfolio for new marketing authorisation applications, investigational applications and variations/supplements,



worldwide Advise to 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 collaboratively with external CMOs and cross-functional teams on projects like process optimizations, scale up and technology transfer activities.

Represent GRDRA during GMP inspections by regulatory agencies, where required Minimum of a bachelor’s degree in a Scientific or Technical Discipline; Advanced Degree strongly preferred. ~7 + years of Regulatory CMC experience; 3 + years experience in Biologics/Biopharmaceuticals (candidates without Biologics experience will not be considered) ~ Sound knowledge of manufacturing technical transfer and comparability regulatory requirements ~ Experience in authoring technical documents, CTD M2 and M3 sections, and life cycle management of quality variations. ~ Proficient in the use of quality management software (e.g. TrackWise) and regulatory document information management system ~ The role can be based in one of our affiliates in Europe. The final offer will reflect the candidate’s skills,



experience, qualifications and internal equity considerations.

This role is eligible to participate in an annual premio scheme, subject to company and individual performance. ~ In addition, we offer a comprehensive benefits package pension, private medical insurance, wellbeing programme, flexible benefits programme. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process.

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support.

Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business.

All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. #

📌 Senior Manager, CMC Regulatory Affairs, Global Rare Diseases (Parma, IT)
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📍 Parma