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 Associate
il y a 2 semaines
Lyon, Auvergne-Rhône-Alpes, France Resourcing Life-Science Temps pleinResponsibilitiesConduct regulatory impact assessments for product changes, including determination of letter-to-file versus submission requirements.Manage annual registrations, license renewals, and ongoing regulatory notifications.Support the preparation, submission, and maintenance of FDA dossiers and related technical documentation.Coordinate the...
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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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Senior Regulatory Affairs Project Manager
il y a 4 jours
Lyon, France Nemera Temps plein**Company Description** With sales of €600m and 3,000 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has...
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Regulatory Affairs Manager M CDI H/F
il y a 6 jours
Lyon, France Nemera Temps pleinWe are currently looking for passionate people ready to make a difference in the following open position: Regulatory Affairs Manager F/M/X, based in Lyon (7e). Within Nemera's headquarters, you will lead the Regulatory & Compliance design projects of drug delivery devices for one of our strategic products BU. You will report to the Quality and Regulatory...
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Regulatory Affairs
il y a 6 jours
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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Quality Assurance Manager and Data Protection
il y a 1 semaine
Lyon 8e, France AXOLTIS PHARMA Temps pleinAxoltis Pharma is a biotechnology company specialized in the treatment of neurodegenerative and traumatic diseases of the central nervous system. With a strong ambition to accelerate our development, we are now looking for a **Quality Assurance Manager and Data Protection Officer (DPO),** **on a full time or part time position**. He/She will supervise...
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Director of Quality Assurance
il y a 7 jours
Lyon, Auvergne-Rhône-Alpes, France Barrington James Temps pleinOverviewOur client is a global leader in pharmaceutical manufacturing, recognised for its expertise in sterile liquid formulations. Operating a large-scale, 24/7 production site with a highly skilled team of professionals, they are now seeking an accomplished Director of Quality & Responsible Pharmacist to drive excellence in product integrity, compliance,...
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Internship - Quality - Regulatory Engineer M H/F
il y a 2 semaines
Lyon, France Nemera Temps pleinLocation: Nemera - Lyon Gerland Site Field: Medical Devices Duration: 6 months Join Nemera, a global leader in medical device solutions, and take part in a strategic project focused on a vaginal applicator produced at our Jaguariúna (Brazil) site. Within the Parenteral & ICO unit, you will support the Quality department in building key regulatory and...
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Quality Assurance Manager and Data Protection Officer
il y a 1 semaine
Lyon, Auvergne-Rhône-Alpes, France Axoltis Pharma Temps pleinAxoltis Pharma is a biotechnology company specialized in the treatment of neurodegenerative and traumatic diseases of the central nervous system.With a strong ambition to accelerate our development, we are now looking for aQuality Assurance Manager and Data Protection Officer (DPO),on a full time or part time (4/5) position.Job DescriptionBased in Lyon and...
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Regional Regulatory Manager
il y a 6 jours
Lyon, France FMC AGRO POLSKA SP. Z O.O. Temps plein**About us** We, FMC Agricultural Solutions, provide innovative crop protection solutions to growers around the world. Thanks to the commitment of our 5,200 employees, we are one of the six largest crop protection manufacturers in the world. For any FMC office located in EU we are looking for a **Regional Regulatory Manager (m/ f/ d)** As a Regional...