Regulatory Operations Specialist
hace 3 horas
Actual Talent is the talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.Si le interesa solicitar este empleo, por favor, asegúrese de cumplir los siguientes requisitos que se enumeran a continuación.Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.About the client:We are seeking a Regulatory Operations Specialist to join one of our clients in the pharmaceutical sector. The position is based in Barcelona and offers a hybrid work model.Your mission:As the Regulatory Operations Specialist, you will support our Regulatory Affairs department by contributing to the analysis and reporting of regulatory data. As part of the transition to a unified platform, this position will ensure consistent recording and use of regulatory data as well as the execution of reporting activities. The role reports to Corporate Head of Regulatory Affairs.Your major accountabilities:In close collaboration with our Corporate RA team and Countries RA teams:Implementing our RIM & DMS project as per the agreed timelines in liaison with our chosen external provider.Contributing with IT team on RA projects requiring data analysis or data migration, as needed.Managing electronic document management systems to ensure compliance and accessibility of regulatory documents.Providing support and guidance on regulatory operations processes to internal & external stakeholders.Managing Pharmacopoeia updates: BP, EP & USP.Staying up to date with the updates in PLM, IDMP, XEVMPD (new compulsory fields).Reviewing & assessing the integration of the local RA folders in each affiliate (local folders vs Corporate folders).Collaborating with cross-functional teams to ensure timely completion of regulatory deliverables.Continuously monitoring and optimizing regulatory operations processes to improve efficiency and compliance.Identifying discrepancies and possible alignments between different systems.Ensuring compliance with the regulatory requirements related to our RA platforms & databases and providing regulatory intelligence to support strategic decision making (new HAs requirements).Proposing process/system improvements to better align/use data for RA activities.Establishing measures/KPIs to improve data quality, efficiency and compliance.Collaborating with relevant RA teams, quality and other departments to ensure alignment & compliance.Updating our internal SOPs related to Reg Operations activities.Liaising with Countries RA teams to keep the RA department updated with relevant changes in Agencies portals (including relevant webinars from EMA/CHMP/HAs).We would like you to have:Bachelor's degree in a scientific or related field; advanced degree preferred.Background in Pharmaceutical Companies in a similar Regulatory Operations role.Minimum of 5 to 7 years of experience in Regulatory Affairs.Proficiency in electronic document management systems (eg eCTD) and regulatory submission software.Be a data-driven professional who thrives working with IT systems & databases.RIMS (Regulatory Information Management System) knowledge and Reporting tools are preferred.Excellent organizational, communication, and problem-solving skills. xsgfvud Fluent in English.
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CMC Regulatory Specialist
hace 1 semana
Plaza Catalunya, España G&L Scientific A tiempo completoPlease note this position can be located in our offices in Barcelona with 2 days on site. Asegúrese de leer la descripción completa a continuación y, si confía en que cumple todos los requisitos, envíe su solicitud de inmediato.G&L Scientific is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance...
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CMC Regulatory Specialist
hace 1 semana
Plaza Catalunya, España G&L Scientific A tiempo completoPlease note this position can be located in our offices in Barcelona with 2 days on site. Asegúrese de leer la descripción completa a continuación y, si confía en que cumple todos los requisitos, envíe su solicitud de inmediato.G&L Scientific is a specialist provider to the healthcare industry for all types of Regulatory Affairs and Quality Assurance...
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Senior People Operations Specialist
hace 3 horas
Plaza Catalunya, España Impress A tiempo completoWe are Impress. We believe everyone deserves a smile that makes them happy! A continuación, encontrará un desglose completo de todo lo que se requiere de los posibles candidatos, así como la forma de presentar su candidatura. ¡Mucha suerte!We are the largest chain of orthodontic clinics in Europe, with fully digital processes. We've revolutionized the...
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Senior People Operations Specialist
hace 3 días
Plaza Catalunya, España Impress A tiempo completoWe are Impress. We believe everyone deserves a smile that makes them happy! A continuación, encontrará un desglose completo de todo lo que se requiere de los posibles candidatos, así como la forma de presentar su candidatura. ¡Mucha suerte!We are the largest chain of orthodontic clinics in Europe, with fully digital processes. We've revolutionized the...
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Quality and Regulatory Director
hace 2 semanas
Plaza Catalunya, España ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Quality and Regulatory Director
hace 3 días
Plaza Catalunya, España ARTO A tiempo completoPosition Overview The Director of Quality and Regulatory Affairs will play a central role in defining and executing the organization’s overall quality and regulatory roadmap. This position oversees the Quality Control, Quality Assurance, and Regulatory Affairs functions, ensuring that operations, systems, and products consistently meet applicable GxP and...
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Operations Specialist
hace 2 semanas
Plaza Catalunya, España Impress A tiempo completoAbout Impress: Join Europe’s #1 orthodontic chain and a leader in Health-Tech innovation. With over 140 clinics across 10 countries, we are combining medical expertise with top-tier technology to revolutionize the invisible aligner market. Por favor, presente su candidatura sin demora si su perfil encaja bien con este puesto, debido al alto nivel de...
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Operations Specialist
hace 3 horas
Plaza Catalunya, España Impress A tiempo completoAbout Impress: Join Europe’s #1 orthodontic chain and a leader in Health-Tech innovation. With over 140 clinics across 10 countries, we are combining medical expertise with top-tier technology to revolutionize the invisible aligner market.Por favor, presente su candidatura sin demora si su perfil encaja bien con este puesto, debido al alto nivel de...
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Regulatory Affairs Specialist Europe
hace 1 día
catalunya, España ManpowerGroup A tiempo completoRegulatory Affairs Specialist Europe Desde ManpowerGroupTalent Solutions estamos buscando a un/a Regulatory Affairs Specialist Europe para el Área de B2B de una multinacional farmacéutica referente en medicamentos genéricos de valor añadido, ubicada en Martorelles. Tu misión dentro del departamento consistirá en garantizar el cumplimiento normativo...
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Regulatory Affairs Specialist
hace 1 día
catalunya, España Prinova Global A tiempo completoRegulatory Affairs Specialist (Full-time, Permanent) Prinova is a leading global supplier of ingredients and premix manufacturing solutions for the food, beverage and nutrition industries. With strategic stocks in 35+ centres around the world and manufacturing facilities in the UK, China and the USA, Prinova’s premix business is underpinned by over 40...
