Corporate Regulatory Compliance Specialist
4 semanas atrás
Chiesi Farmaceutici S.p.A. is a leading international research-focused pharmaceutical and healthcare group with over 85 years of experience. We operate in 31 countries with more than 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.
Job Title: Corporate Regulatory Compliance SpecialistWe are seeking a highly skilled Corporate Regulatory Compliance Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality compliance to pharmaceutical standards and internal procedures.
Main Responsibilities:- Ensure the quality compliance to pharmaceutical standards and internal procedures;
- Guarantee the regulatory compliance of production and analytical documents and processes to Global registration dossier;
- Provide Global Products life-cycle regulatory support (i.e. CMC documentation review, deficiency letter responses, documentation for first registration);
- Manage Global Products lifecycle quality activities (i.e. item codes attributes on SAP system, materials specifications on LIMS system);
- Support to life-cycle changes assessment and to the implementation phase;
- Bridge activities between manufacturing plants (internal and external) and Global Regulatory Affairs.
- At least 4-5 years of experience in Regulatory or Quality Assurance positions in the pharmaceutical industry;
- Degree in scientific disciplines (CTF, Chemistry, Biology, Pharmacy);
- Fluent English (both written and spoken);
- Knowledge of applicable national and international legislation (EMA, FDA, ICH guidelines, etc.);
- Knowledge of reference pharmacopoeias monographs (EP, USP mainly);
- Knowledge of GMP and Quality Systems;
- Knowledge of AIFA regulations;
- Knowledge of regulatory framework and registration dossier of MAH.
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 to 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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