Global Regulatory Lead
5 giorni fa
Date: 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 7,000 employees. To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas. We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards . We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels. We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors . Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. Chiesi Research & Development Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China). Who 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 Contributes to company success with collaboration from Therapeutic Area (TA) head Accountable for global/regional regulatory strategies for new and existing products by leading the Global Regulatory Team (GRT) for assigned projects Participates in OMNIS Development Core Teams Leads according to established best practices 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 standards When required, act as single point of regulatory contact during inspections from health authorities Manages pre-approval and post approval activities, as needed and in agreement within the GRT Maintains relationships with the health authorities, developing in-depth knowledge of relevant regulations and requirements Provides as needed support to IMDD, Affiliates, and Partners for prioritized issues and topics 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 etc Experience Required At least ten years of experience within Regulatory Affairs of which at least five in the global context Education University degree in a scientific discipline, such as Chemistry, Pharmacy, Chemistry and Pharmaceutical Technology, Human Medicine, Biological Science, Biotechnology Languages Written and spoken English Technical Skills Knowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidance Soft Skills Emotional and social intelligence Leadership and social influence Planning and organizational skills Strategic thinking What we offer You 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. J-18808-Ljbffr
-
Global Regulatory Lead
5 mesi fa
Parma, Italia Chiesi Group A tempo pienoWho 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...
-
Global Regulatory Lead
5 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...
-
Global Regulatory Lead
2 mesi fa
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...
-
Global Regulatory Lead
2 mesi fa
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...
-
Global Regulatory Lead
2 mesi fa
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...
-
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...
-
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...
-
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...
-
Global Regulatory Affairs Senior Project Manager
4 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...
-
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...
-
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...
-
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...
-
Global Regulatory Affairs Senior Project Manager
6 giorni 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...
-
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...
-
Pharmacovigilance Operations Lead
3 giorni fa
Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pieno**About Chiesi Farmaceutici S.P.A.**Based in Parma, Italy, Chiesi is a research-focused pharmaceutical and healthcare group with over 85 years of experience, operating in 31 countries with more than 7,000 employees.To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches,...
-
Parma, Emilia-Romagna, Italia Chiesi Group A tempo pienoJob DescriptionWe are seeking a highly skilled Global Pharmacovigilance Operations Manager to join our team. As a key member of our R&D department, you will play a crucial role in ensuring the successful execution and oversight of pharmacovigilance operations activities within our Air Business Unit.Main ResponsibilitiesCollaborate with the Global PV...
-
Parma, Italia Chiesi Group A tempo pienoWho we are looking for Purpose Ensure 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 management Main...
-
Global Pm Supply Lead
7 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...
-
Regulatory Compliance Manager
4 giorni fa
Parma, Emilia-Romagna, Italia Sidel A tempo pienoJob DescriptionSidel is seeking a highly skilled Regulatory Compliance Manager to join our team in Parma, Italy.About the RoleWe are looking for an experienced professional to lead and coordinate the implementation of European and international regulations related to the safety of Sidel machines. As a key member of our team, you will be responsible for...
-
Global Pharmacovigilance Director
2 settimane fa
Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pienoDiscover a challenging career opportunity as Global Pharmacovigilance Director at Chiesi Farmaceutici S.P.A., a renowned international research-focused pharmaceutical and healthcare group. Our team is dedicated to improving people's quality of life by acting responsibly towards society and the environment.About UsWe are based in Parma, Italy, and operate in...
