Quality Assurance and Regulatory Affairs France
il y a 2 jours
The Pharmaceuticals Affairs intern supports pharmaceuticals affairs activities of Valneva France SAS as defined in article R.5124-2-3: Quality assurance, Wholesaling, Advertising, Regulatory Affairs. All activities are performed under the Pharmacien Responsable supervision. **Responsibilities**: > Exploitant/Distributor Quality Assurance › Support implementation, maintenance and improvement of the Quality Management System (QMS) of VALNEVA France SAS in line with the Group Quality Policies, GMP/GDP&GVP guidelines and Public Health Code › Contributing to continuous improvement of the Exploitant through risk analysis › Support management of deviations/CAPAs/Change control management › Support management of Product Technical Complaints (PTC) management › Participate to Self-inspection/audit if need be › Support suppliers qualification/management > Regulatory affairs › Recording MA modification of the marketed products in dedicated tracking table › Reviewing packaging material of the product intended to be market on the territory, › Assisting the department in the management of out of stock situation (review of PGP, ) > Advertising › Support the department in the control of promotional activities. **Requirements**: Education /Experience: - 5th or 6th year student in pharmacy - Ideally a master degree in regulatory/quality affairs planned or on-going **Required Skills**: - Fluent in English, both written and spoken, - Ideally knowledge of GxP and Exploitant regulation - Sense of responsibility, - Good organizational skills, - Understanding of potential public health issues related to activity, - Ability to demonstrate ethics and confidentiality
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Regulatory Affairs Officer
il y a 2 semaines
Lyon, France Astek Temps pleinRegulatory Affairs Officer - Lyon, France (F/M)Join to apply for the Regulatory Affairs Officer - Lyon, France (F/M) role at Astek.About UsAlsinova, a subsidiary of the Astek Group, specializes in Life Sciences. We support pharmaceutical, biotech, and medtech companies with expertise in regulatory affairs, clinical development, data, quality, and...
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Regulatory Affairs Officer
il y a 1 semaine
Lyon, Auvergne-Rhône-Alpes, France Astek Temps pleinWhat We Will Accomplish TogetherAlsinova, asubsidiary of the Astek Group, is a consulting firm specialized inLife Sciences. We support pharmaceutical, biotech, and medtech companies by providing high-level expertise inregulatory affairs, clinical development, data, quality, and pharmacovigilance. To support one of our major partners in thein vitro...
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Quality Assurance Manager
il y a 2 semaines
Lyon, France Lyonbiopôle Temps pleinAs Quality Assurance Coordinator at AUROBAC, you will be responsible for implementing, monitoring and continuously improving the quality management system. You will play a key role in ensuring compliance with current regulations and in supporting the R&D teams in guaranteeing process conformity.The Quality Assurance Coordinator will report to the Quality and...
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Lyon, France Excelya Temps plein**About the Job** Join Excelya, where **Audacity, Care, and Energy** define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play...
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Regulatory Affairs
il y a 2 semaines
Lyon, France Alan Temps pleinRegulatory Affairs & Governance Lead – Alan Alan is a vertically integrated health partner that seamlessly unites insurance and smart healthcare delivery into one system. Our mission is to help people live in good health while turning employer health benefits into a valuable investment. About the Role The Risk team drives Alan’s resilience by guiding...
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Regulatory Affairs Officer F
il y a 2 semaines
Lyon, France Astek Temps pleinAlsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector. Your mission (should you decide to accept it) As a Regulatory Affairs Officer, you will contribute to ensuring that the company's IVD products remain compliant with the evolving IVDR regulations...
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Cdi - Product Regulatory Affairs Specialist - F/m
il y a 3 jours
Lyon, France bioMérieux sa Temps pleinA family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution...
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Regulatory Affairs
il y a 2 semaines
Lyon, Auvergne-Rhône-Alpes, France Alan Temps pleinWho we areYou. Better. With Alan.Alan's vision is to make prevention the new norm of care for all.Our mission is to help people live in good health to 100 while helping employers feel proud, turning health benefits from a cost centre into their most valuable investment.We're building avertically integrated health partnerthat seamlessly unites insurance and...
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IVDR Regulatory Affairs Specialist – IVD Compliance
il y a 2 semaines
Lyon, France Astek Temps pleinA leading CRO solutions provider is recruiting a Senior Preclinical Biostatistician in Lyon, France. The role focuses on ensuring compliance with evolving IVDR regulations. Candidates should have a higher education in Life Sciences and 2-5 years of experience in regulatory affairs for medical devices or IVDs. Key responsibilities include preparing technical...
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Regulatory Affairs Specialist
il y a 2 semaines
Lyon, France ResMed Inc Temps pleinRegulatory Affairs Specialist page is loaded## Regulatory Affairs Specialistlocations: Saint-Priest, Lyon, Francetime type: Full timeposted on: Posted Todayjob requisition id: JR\_046400**Contexte et objectifs du poste**Au sein de l’équipe Regulatory Affairs EMEA, vous jouerez un rôle clé dans la gestion de toutes les activités réglementaires...