Corporate Regulatory Compliance Senior Specialist
Date: Feb 6, 2025
Department: Corporate Quality Operations
Job Type: Direct Employee
Team: Quality
Contract Type: Permanent
Location: Parma, IT
About us
Based in Parma, Italy, Chiesi is an...
Plan [DMP], Prescription Drug Monitoring Program [PDMP], Case Report Form [CRF], Clinical Study Report [CSR])
• Provide high-quality and timely statistical analyses results to support correct and timely decision making.
• Act as a statistical...
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Team: R&D, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee
Contract Type: Permanent
Location: Parma, IT
About us
Based in Parma, Italy, Chiesi is an international research...
Management: Manage the R&D budget and allocate resources effectively to maximize productivity and innovation.
• Regulatory Compliance: Ensure all R&D activities comply with regulatory requirements and quality standards.
• Reporting: Prepare and present...
a plus.
Languages
Technical Skills
• Knowledge of national and international regulatory safety reporting requirements (post-marketing and clinical trials)
• Knowledge of MedDRA coding dictionary and its principles
• Ability in managing performance...
feels better' and' ultimately' lives better thanks to microorganisms and biotransformation. Job Description Reporting to the QA Manager' you will collaborate in the management of tasks related to Regulatory Affairs and Compliance.
Your main...
Manager. The role will report to the Emerging Risks And Risk Assessment Associate Director and will be based in Parma.
Job purpose
The role is responsible for overseeing and ensuring compliance with food safety regulations and guidelines related to...
/ Transportation validation.
• Develop and review quality documentation and procedures as requested.
• Implement and manage training on GDP and QMS documentation.
• Assist with preparation of status report metrics for deviations, CAPAs and Change Control/Management...