Chiesi Group
5001 - 10000 employees
💊 Pharmaceuticals
⚕️ Healthcare Insurance
🧬 Biotechnology
Pharmaceuticals • Healthcare Insurance • Biotechnology
Chiesi Group is a global pharmaceutical company that focuses on the research, development, and commercialization of innovative medicines. Known for its commitment to improving the lives of patients, the company specializes in areas such as respiratory diseases, special care, and rare diseases. Chiesi Group emphasizes sustainability and corporate responsibility, aiming to enhance health and well-being across the globe while also being dedicated to environmental stewardship.
Specialist Care Therapeutic Area, Global Regulatory Affairs and Patient Safety
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Chiesi Group
5001 - 10000 employees
💊 Pharmaceuticals
⚕️ Healthcare Insurance
🧬 Biotechnology
Pharmaceuticals • Healthcare Insurance • Biotechnology
Chiesi Group is a global pharmaceutical company that focuses on the research, development, and commercialization of innovative medicines. Known for its commitment to improving the lives of patients, the company specializes in areas such as respiratory diseases, special care, and rare diseases. Chiesi Group emphasizes sustainability and corporate responsibility, aiming to enhance health and well-being across the globe while also being dedicated to environmental stewardship.
📋 Description
• May serve as a regional/local regulatory lead and point of contact both internally and with competent national authorities in EU countries and EMA. • Contribute (independently or with GRL/ Manager guidance) to the development of global HA interaction strategy in collaboration with GRT members • Accountable for developing, singly or with GRL guidance/Manager support, the HA engagement & interaction plans for assigned products incl. authoring, leading & moderating preparation meetings • Accountable for complete and accurate communication/interaction (including tracking in relevant systems) with the HAs, affiliates and IMDD partners for the projects/products in their remit • Lead, independently or with GRL guidance, regulatory subteam to ensure NDA/BLA/ MAA/Extensions/Variations/Renewals filings meet the project timelines • Collaborate with Project Manager to develop core global dossier and collaborate with other GRT members as appropriate • Ensure regulatory submission timelines are aligned with program level and company objectives • Contribute to content and reviews for regulated documents • Support operational and compliance activities for assigned deliverables • Support GMP, GCP, and GPV inspections from health authorities • Accountable to provide updates on project and submissions status to GRT members • Accountable to support the GRL on updates to the Affiliates and interactions with IMDD and partners
🎯 Requirements
• Experience in regulatory lifecycle management in Europe, particularly with MRP/DCP and centralized procedures. • Fluent English • Excellent attention to detail, including data consistency, traceability, and alignment across submission documents • Ability to solve problems proactively and problem solving skills and the ability to work both independently and collaboratively in multidisciplinary team • Fluent English • Experience with FDA • Experience with biological products
🏖️ Benefits
• Comprehensive healthcare programs • Work-life balance initiatives • Robust relocation support • Flexible working arrangements • Remote work options • Tax assistance services for foreign colleagues
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