Corporate Regulatory Compliance Senior Specialist

Who we are looking for Purpose The Corporate Regulatory Compliance Senior Specialist will report to the Head of Global Product Compliance and will be focused on products related to the Rare Diseases Business Unit.
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.
Experience Required At least 4-5 years of experience in Regulatory or Quality Assurance positions in the pharmaceutical industry.
Education Degree in scientific disciplines (CTF, Chemistry, Biology, Pharmacy).
Languages 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 get used 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 stressfull situations.   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 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.