Global Regulatory Lead
5 mesi fa
Who we are looking forPurposeThe 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 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 R&D 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 thinkingWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development.
Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best.
That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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Global Regulatory Lead
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Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoJob SummaryThe Global Regulatory Lead is a critical role within the Chiesi Group, responsible for managing the Corporate R&D Pipeline and providing regulatory guidance to the R&D Global Core Team.Main ResponsibilitiesContribute to company success through collaboration with the Therapeutic Area head.Develop and lead global/regional regulatory strategies for...
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Global Regulatory Lead
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Parma, Italia Tn Italy A tempo pienocol-wideJob Description:Who we are looking forPurposeThe 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 Responsibilities1) Contributes to company success with...
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Global Regulatory Lead
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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
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Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 2 Oct 2024 Department: Global Regulatory Affairs Team: RD, Pharmacovigilance Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About 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...
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Global Regulatory Lead
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Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 2 Oct 2024 Department: Global Regulatory Affairs 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-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than...
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Global Regulatory Lead
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Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 2 Oct 2024 Department: Global Regulatory Affairs 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-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with...
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Global Regulatory Lead
4 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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Global Regulatory Lead
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Parma, Emilia-Romagna, Italia Chiesi A tempo pienoAbout UsChiesi is an international research-focused pharmaceutical and healthcare group with a rich history and a strong commitment to improving people's quality of life. As a leader in the industry, we strive to make a positive impact on society and the environment.Our MissionAt Chiesi, we believe that our success is built on the strength of our people and...
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Global Regulatory Lead
4 settimane fa
Parma, Emilia-Romagna, Italia Chiesi A tempo pienoJob DescriptionAt Chiesi, we are seeking a highly skilled Global Regulatory Lead to contribute to our company's success by managing the Corporate R&D Pipeline.Main ResponsibilitiesCollaborate with the Therapeutic Area head to contribute to company success.Develop and lead global/regional regulatory strategies for new and existing products as the leader...
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Parma, Emilia-Romagna, Italia Chiesi Farmaceutici A tempo pienoJob Title: Global Regulatory Affairs Senior Project ManagerAbout the Role:We are seeking a highly skilled Global Regulatory Affairs Senior Project Manager to join our team at Chiesi Farmaceutici. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring the coordination and management of regulatory digital projects and...
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Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoJob SummaryWe are seeking a highly skilled Global Regulatory Affairs Senior Project Manager to join our team at Chiesi Group. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring the coordination and management of regulatory digital projects and initiatives throughout their lifecycle.Main ResponsibilitiesDevelop and...
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Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 8 Oct 2024 Department: Global Regulatory Affairs Team: RD, Pharmacovigilance Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About 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...
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Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 8 Oct 2024Department: Global Regulatory AffairsTeam: 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...
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Global Regulatory Affairs Senior Project Manager
3 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 8 Oct 2024 Department: Global Regulatory Affairs 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-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with...
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Parma, Italia Chiesi Group A tempo pienoWho we are looking forPurposeEnsure coordination and management of regulatory digital projects and initiatives during each phase (discovery, planning, execution, launch and maintenance) Ensure adequate execution of cross functional projects, participate on project team as expert in regulatory digital project managementMain ResponsibilitiesEnsure proper...
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Global Regulatory Affairs Senior Project Manager
3 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 8 Oct 2024 Department: Global Regulatory Affairs 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-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with...
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Global Regulatory Affairs Senior Project Manager
3 settimane fa
Parma, Italia Chiesi Farmaceutici A tempo pienoDate: 8 Oct 2024Department: Global Regulatory AffairsTeam: R&D, 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...
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Global Regulatory Affairs Project Manager
4 settimane fa
Parma, Emilia-Romagna, Italia Chiesi A tempo pienoAbout UsChiesi is a leading international research-focused pharmaceutical and healthcare group with a rich history of over 85 years. Headquartered in Parma, Italy, the company operates in 31 countries with a strong presence of over 7,000 employees. Our mission is to improve people's quality of life by acting responsibly towards society and the environment....
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Senior Regulatory Affairs Project Manager
3 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoMain ResponsibilitiesProject Planning and Coordination: Ensure proper project planning and execution for digital regulatory initiatives with the development of detailed project plans, timelines, and budgets and coordination of project activities, ensuring tasks are assigned, tracked, and completed on schedule.Project Monitoring and Risk Management: Monitor...
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Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pienoSelect how often (in days) to receive an alert:Digital Regulatory Project Senior SpecialistDate: 8 Oct 2024Department: Global Regulatory AffairsTeam: 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...
