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About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here
We are proud to have been awarded with B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
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.
The unit is headquartered in Boston, Massachusetts, and has an initial focus on research and product development for lysosomal storage diseases, rare hematology and ophthalmology disorders. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care.
What we are looking for
Main Responsibilities
* Prepares, compiles, and maintains CMC regulatory documents to support a broad range of submissions to regulatory authorities within a given timeline, according to the regulatory strategy agreed by GRDRA region Head/Manager worldwide and GRDRA CMC Head, in close collaboration with personnel in the Global Rare Disease commercial team.
* Authors and/or reviews Chemistry, Manufacturing and Controls (CMC) sections of new marketing authorisation applications and investigational applications of Global Rare Disease products, worldwide.
* In alignment with GRDRA CMC Head, advises and provides guidance to multidisciplinary project teams regarding regulatory agency requirements and expectations pertaining to CMC sections of regulatory submission dossier.
* Reviews and assesses change control requests pertaining to CMC aspects of GRD products.
* With the support of the GRDRA region Head/Manager worldwide, and in alignment with GRDRA CMC Head, agrees on the regulatory strategy for the GRD products life cycle.
* Authors and/or reviews CMC sections of regulatory submissions for the life cycle activities on Global Rare Disease products, worldwide.
* Upon agreement with GRDRA CMC Head, interacts with regulatory agencies, as applicable, to negotiate strategies and actions associated with the CMC sections of regulatory submissions, in strict collaboration with the GRDRA region Head/Manager.
* In collaboration with external CMO coordinates the preparation of submission package of CMC sections of regulatory submission dossier.
* Contributes to the development of processes and the preparation of Standard Operating Documents for Global Rare Disease RA.
* Upon agreement with GRDRA CMC Head, supports due diligence activities on CMC regulatory documents.
* Upon agreement with GRDRA CMC Head, represents GRDRA during GMP inspections by regulatory agencies.
Experience Required
* Experience and knowledge in new MAAs and in the life cycle management of registered MAs.
Education
Master's Degree
Languages
English fluent
Technical Skills
* Ability to work independently in the preparation of high-quality CMC sections of regulatory submissions.
Soft Skills
* Attention to details
* Communication skills
* Analytical skills
* Team working
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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