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Regulatory Compliance Specialist
2 mesi fa
As a key member of the Chiesi Group, you will be responsible for ensuring the quality compliance to pharmaceutical standards and internal procedures. This includes guaranteeing the regulatory compliance of production and analytical documents and processes to Global registration dossier.
Key Activities• Provide Global Products life-cycle regulatory support, including CMC documentation review, deficiency letter responses, and documentation for first registration.
• Manage Global Products lifecycle quality activities, such as item codes attributes on SAP system and materials specifications on LIMS system.
• Support life-cycle changes assessment and implementation phase.
• Bridge activities between manufacturing plants (internal and external) and Global Regulatory Affairs.
Requirements• 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).
Technical Skills• 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.
Soft Skills• Ability to quickly adapt to new, dynamic, and multicultural working environments.
• Attitude to problem-solving and flexibility to find new solutions and alternative routes.
• Organizational skills and time management skills.
• Goal-oriented approach and respect of deadlines.
• Ability to establish good professional collaborations with members of a work group, even under stressful situations.
What We OfferYou will join a dynamic, fast-growing, challenging, and friendly environment. At Chiesi, we believe that our people are our most valuable asset, which is why we invest in continuous training, learning, and development. We strive to 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 give our best. That is why we offer flexible working approaches, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services.
