Compliance

• Supportare l'implementazione e la manutenzione di un programma di conformità in linea con il GDPR
• Monitorare gli sviluppi delle leggi di protezione dei dati
• Concludere valutazioni di impatto sulla protezione dei dati (DPIA)
• Gestire e rispondere alle richieste dei soggetti interessati
• Mantenere e aggiornare i registri delle attività di trattamento (RoPA)

Privacy & Compliance Specialist

• Presidia le attività di compliance normativa, gestione documentale e governance organizzativa.
• Coordinamento della raccolta documentale per audit, certificazioni e assessment.
• Supporto al mantenimento dei sistemi di gestione certificati.
• Monitoraggio delle principali scadenze normative e organizzative.
• Collaborazione con responsabili di funzione per garantire il corretto allineamento ai framework normativi applicabili.

Compliance & Governance Specialist – Cat. Protette, L.68/99

• Maintain or create CMC regulatory documents for product submissions
• Manage CMC regulatory documents in collaboration with the Core team
• Advise project teams on regulatory agency requirements
• Review change control requests pertaining to CMC aspects
• Agree on regulatory strategy for GRD products' life cycle
• Maintain submission information and track commitments
• Work with external CMOs and cross-functional teams
• Support development of processes and Standard Operating Procedures
• Represent GRDRA during GMP inspections
• Keep abreast of current regulatory CMC requirements

Manager, CMC Regulatory Affairs – Global Rare Diseases

• Analisi e valutazione delle modalità di vendita dei canali e della rete partner in conformità alle normative di settore.
• Attività di monitoraggio e controllo della produzione dei partner in ottica di accountability dei dati.
• Analisi delle iniziative di trattamento dei dati personali gestite dalla Società.
• Analisi normativa e conseguente valutazione del rischio rispetto all'esposizione della Società.

Specialista Compliance Processi Commerciali, Privacy

• develop regulatory strategies for EU & International markets
• plan, coordinate and manage regulatory submissions to regional agencies
• provide advice and guidance regarding regional regulatory requirements
• contribute to the preparation and/or review of submissions to relevant markets
• communicate directly with regional regulatory authorities on behalf of Chiesi GRD
• review regulatory submission documents, periodic updates, overviews, summaries
• develop processes and prepare Standard Operating Documents for GRD Regulatory Affairs
• provide regulatory guidance to colleagues from other functional areas
• represent the Regulatory Department at the Core Team as a global RA member

Manager, EU & International Regulatory Affairs – Global Rare Diseases

• Provide regulatory input to new product development and product lifecycle planning mainly for Global Surgical Solutions product portfolio (Operating Lights, Operating Tables and Accessories)
• Generation of documentation and procedures relating to product development, manufacturing, and quality control in accordance with regulatory standards
• Ensure compliance with regulations (e.g. 21 CFR 820, MDR), standards (ISO 13485), and the quality manual and internal procedures.
• Work closely with product development, clinical, and marketing teams to gain required information for new product submissions and provide regulatory advice to project teams as required (Example: DHF/Technical Documentation maintenance)
• Review documents, including Clinical Evaluation reports, risk analysis, FMEA, reports, labeling, advertising, promotion and marketing literature
• Assist with document control, including document review, approval, archiving, maintenance of document list, and working with other functional groups on development of new processes or procedures
• Maintain regulatory files in a format consistent with requirements
• Assess the acceptability of quality, preclinical and clinical documentation for regulatory submission filing
• Monitor applications under regulatory review
• Communicate application progress to internal stakeholders
• Communicate preapproval compliance activities
• Ensure compliance with product post-marketing approval requirements
• Ensure external communications meet regulations
• Identify emerging issues for Regulatory Compliance
• Provide regulatory input for product recalls, recall communications, and CAPAs, (where necessary)
• Provide MDR updates/guidance to product development teams

Compliance jobs in Italy

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Privacy & Compliance Specialist

Compliance & Governance Specialist – Cat. Protette, L.68/99

Manager, CMC Regulatory Affairs – Global Rare Diseases

Specialista Compliance Processi Commerciali, Privacy

Manager, EU & International Regulatory Affairs – Global Rare Diseases

Regulatory Affairs Specialist – Temporary