Lavori attuali relativi a Global Regulatory Lead - Parma - Chiesi Farmaceutici S.P.A.
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Global Regulatory Lead
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Purpose The Global Regulatory Lead contributes to the Company’s success by managing the Corporate R&D Pipeline (projects in R&D Development) by providing regulatory guidance to the R&D Global Core Team as well as other non-R&D functions, as needed. Main Responsibilities 1) Contributes to company...
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Global Regulatory Lead
1 mese fa
Parma, Italia Chiesi A tempo pienoAbout 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...
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Global CMC Regulatory Affairs Senior Specialist
1 settimana fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoWho We Are Looking For Purpose Responsible for: • Developing and implementing comprehensive and innovative Regulatory-CMC strategies globally, covering the entire product life-cycle (pre-clinical, clinical, post-market and change management) for Chiesi's global offerings, including chemically synthesized products, biologics, and medical devices...
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Global CMC Regulatory Affairs Senior Expert
3 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoWho We Are Looking For Purpose Responsible for: • Developing and implementing comprehensive and innovative Regulatory-CMC strategies on a global scale, covering the entire product life-cycle (from pre-clinical to clinical phases, as well as life-cycle and change management) for Chiesi's global offerings, including chemically synthesized products,...
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Specialist, Labelling
2 mesi fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoSpecialist, Labelling Compliance Regulatory Affairs, Global Rare DiseasesDate: Jul 11, 2024Department: GRD Regulatory AffairsJob Type: Direct EmployeeTeam: RD, Pharmacovigilance Regulatory AffairsContract Type: PermanentLocation: Parma, ITPurposeTo contribute to and oversee GRDRA regulatory information and documentation managed in RIMS and eDMS, and to...
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Specialist, Labelling
2 mesi fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoSpecialist, Labelling & Compliance Regulatory Affairs, Global Rare DiseasesDate: Jul 11, 2024Department: GRD Regulatory AffairsJob Type: Direct EmployeeTeam: R&D, Pharmacovigilance & Regulatory AffairsContract Type: PermanentLocation: Parma, ITPurposeTo contribute to and oversee GRDRA regulatory information and documentation managed in RIMS and eDMS, and to...
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Global Reg-Cmc Sr. Specialist
3 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking forPurposeAccountable for:• Pursuing and executing global, robust and innovative Regulatory-CMC strategies, across the entire life-cycle (pre-clinical, clinical, life-cycle and change management) of Chiesi global products and projects, intended as chemically synthetized or biologics DS, DP, medical devices (including the device...
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Global Pm Supply Lead
4 mesi fa
Parma, Italia Sidel A tempo pienoWe are looking for a Global PM Supply Lead. The resource will manage customer's projects by coordinating the local Equipment Supply Team in the different Production Centers. **Your Mission**: - Overall project planning & milestones. - Update physical progress of the projects. - Project incurred cost compared to total initial costs, correlated with physical...
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Regulatory Compliance Specialist
3 giorni fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoMain ResponsibilitiesAs a key member of the Chiesi Group, you will be responsible for ensuring the quality compliance to pharmaceutical standards and internal procedures. This includes guaranteeing the regulatory compliance of production and analytical documents and processes to Global registration dossier.Key Activities• Provide Global Products life-cycle...
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Regulatory Compliance Specialist
1 giorno fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoMain ResponsibilitiesAs a key member of the Chiesi Group, you will be responsible for ensuring the quality compliance to pharmaceutical standards and internal procedures. This includes guaranteeing the regulatory compliance of production and analytical documents and processes to Global registration dossier.Key Activities• Provide Global Products life-cycle...
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Global Reg-Cmc Sr. Specialist
1 mese fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoTeam: RD, Pharmacovigilance Regulatory AffairsJob Type: Direct EmployeeContract 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...
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Parma, Italia Chiesi Group A tempo pienoWho 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,...
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Global Reg-CMC Sr. Specialist
3 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Purpose Accountable for: • Pursuing and executing global, robust and innovative Regulatory-CMC strategies, across the entire life-cycle (pre-clinical, clinical, life-cycle and change management) of Chiesi global products and projects, intended as chemically synthetized or biologics DS, DP, medical devices...
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Regulatory Affairs Specialist
3 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoAbout UsChiesi is a global, research-driven pharmaceutical and healthcare organization with a legacy of over 85 years, operating across 31 countries and employing more than 7,000 individuals. Our mission is to enhance the quality of life for individuals while maintaining a responsible approach towards society and the environment. We focus on the research,...
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Regulatory Affairs Specialist
1 giorno fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoAbout UsChiesi is a global, research-driven pharmaceutical and healthcare organization with a legacy of over 85 years, operating across 31 countries and employing more than 7,000 individuals. Our mission is to enhance the quality of life for individuals while maintaining a responsible approach towards society and the environment. We focus on the research,...
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Global Reg-Cmc Sr. Specialist
1 mese fa
Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoTeam: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout us Based 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...
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Global Reg-CMC Sr. Specialist
3 mesi fa
Parma, Italia Chiesi A tempo pienoAbout 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...
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Specialist, Labelling
2 mesi fa
Parma, Italia Chiesi Group A tempo pienoAbout us Based 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...
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Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoWho we are looking for Main Responsibilities • Ensure adherence to pharmaceutical standards and internal protocols; • Safeguard the regulatory integrity of production and analytical documentation and processes in line with Global registration requirements; • Provide comprehensive regulatory support throughout the Global Products life-cycle...
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Regulatory Compliance Specialist in Pharmaceuticals
3 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoWho we are looking for Main Responsibilities • Ensure adherence to pharmaceutical standards and internal protocols; • Safeguard the regulatory integrity of production and analytical documentation and processes in line with Global registration requirements; • Provide comprehensive regulatory support throughout the Global Products life-cycle...
Global Regulatory Lead
2 mesi fa
Main Responsibilities1) Contributes to company success with collaboration from Therapeutic Area (TA) head2) Accountable for global/regional regulatory strategies for new and existing products by leading the Global Regulatory Team (GRT) for assigned projects3) Participates in OMNIS Development Core Teams 4) Leads according to established best practices5) Manages and leads the preparation and review of regulatory applications, reports, and correspondence in a manner that ensures timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards6) When required, act as single point of regulatory contact during inspections from health authorities7) Manages pre-approval and post approval activities, as needed and in agreement within the GRT8) Maintains relationships with the health authorities, developing in-depth knowledge of relevant regulations and requirements9) Provides as needed support to IMDD, Affiliates, and Partners for prioritized issues and topics10) Maintains close relationships with RD functions and Therapeutic areas; i.e., participates in and manage core team relationships or represent GRT to TAM or XRC etcExperience RequiredAt least ten years of experience within Regulatory Affairs of which at least five in the global contextEducationUniversity degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, BiotechnologyLanguagesWritten and spoken EnglishTechnical SkillsKnowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidanceSoft SkillsEmotional and social intelligenceLeadership and social influencePlanning and organizational skillsStrategic thinking #J-18808-Ljbffr
