Regulatory Compliance Specialist
Há 6 dias
We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Chiesi Farmaceutici S.p.A. in Parma, Italy.
Main Responsibilities- Ensure quality compliance to pharmaceutical standards and internal procedures.
- Guarantee 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 life-cycle changes assessment and 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.
- A dynamic, fast-growing, challenging and friendly environment.
- Continuous training, learning and development opportunities.
- A focus on quality of working environment and collective well-being.
- A flexible working approach and remote working options.
- Support in relocation process and tax assistance service for foreign colleagues.
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