Corporate Regulatory Compliance SpecialistDepartment: Corporate Quality OperationsJob Type: Direct EmployeeTeam: Industrial Operations & HSEContract Type: PermanentLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 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.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 Manufacturing DivisionChiesi Group has three production plants: Parma (Italy); Blois-La Chaussée-Saint-Victor (France); Santana de Parnaíba (Brazil). The plants produce a total of over 110 million units per year.The production plant in Parma covers a total area of more than fifteen thousand square meters and it is the strategic hub for the production and distribution of our products, being an international supply center that exports to more than 80 countries. The Parma plant produces solid medicinal products, such as tablets and inhaled dry powders; inhalation solutions and suspensions, either pressurized or sterile single-dose vials; vials of sterile suspension for endotracheal administration; liquid forms such as drops, syrups and nasal sprays.Santana produces pressurized solutions and suspensions for inhalant therapy (MDIs) and supplies both domestic market and Group's Affiliates and exports to licensees and distributors. Blois specializes in Dry Powder Inhalers and final assembly stages of the Metered-Dose Inhalers (MDIs), supplies Group's Affiliates and distributes directly to clients at a local level and in export markets.Who we are looking forMain Responsibilities• Ensure the quality compliance to pharmaceutical standards and to 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 RequiredAt least 4-5 years of experience in Regulatory or Quality Assurance positions in the pharmaceutical industryEducationDegree in scientific disciplines (CTF, Chemistry, Biology, Pharmacy)LanguagesFluent 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 offerYou 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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