Lavori attuali relativi a Global Regulatory Lead - Bologna - Buscojobs
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Manager, Global Quality Assurance
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BOLOGNA, Italia Alira Health Group A tempo pienoManager, Global Quality Assurance page is loadedManager, Global Quality AssuranceApply remote type Hybrid locations Verona Bologna-Remote Barcelona-Remote Padova-Remote Verona-Remote time type Full time posted on Posted Yesterday job requisition id JR000288Join our global team dedicated to innovation and initiative, where physical walls and different time...
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Manager, Global Quality Assurance
4 giorni fa
Bologna, Italia Alira Health Group A tempo pienoManager, Global Quality Assurance page is loadedManager, Global Quality AssuranceApply remote type Hybrid locations Verona Bologna-Remote Barcelona-Remote Padova-Remote Verona-Remote time type Full time posted on Posted Yesterday job requisition id JR000288Join our global team dedicated to innovation and initiative, where physical walls and different time...
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Manager, Global Quality Assurance
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BOLOGNA, Italia Alira Health Group A tempo pienoManager, Global Quality Assurance page is loaded Manager, Global Quality Assurance Apply remote type Hybrid locations Verona Bologna-Remote Barcelona-Remote Padova-Remote Verona-Remote time type Full time posted on Posted Yesterday job requisition id JR000288 Join our global team dedicated to innovation and initiative, where physical walls and different time...
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Quality Assurance
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Global Regulatory Lead
4 settimane fa
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.
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