Regulatory Affairs Manager
hace 6 días
This role can be based in either our Barcelona, Belfast or London Office. We work on a hybrid basis.Ready to dive into some seriously meaningful science? We're looking for a seasoned CMC Regulatory Affairs pro who loves complex challenges, global coordination, and shaping regulatory strategy for a high-impact vaccine portfolio. You'll step in as our Senior Regulatory Strategist, owning several major upcoming submissions—including:Swapping out an in vivo potency assay for a shiny new in vitro methodImplementing new potency reference vaccine replacementsIf leading cross-functional teams, navigating global health authorities, and crafting impeccable regulatory dossiers sounds like your kind of adventure, read on. EducationMaster's degree or higher in chemistry, pharmacy, biology, or similar (we'll be extra impressed if you have a PhD). What You BringDemonstrable significant experience in CMC Regulatory Affairs—bonus points if you've wrangled global lifecycle submissions for vaccines.Hands-on experience with:Registering new analytical methodsPotency assay development and validationReference standard strategy and maintenanceA proven track record of leading multiple projects, shaping CMC regulatory strategy, and authoring major submissions (BLAs, MAAs, variations—your bread and butter).Deep understanding of how vaccines are developed, manufactured, tested, and shipped.Fluency in global CMC frameworks: EMA, FDA, WHO, and friends.Confidence and skill in influencing, negotiating, and keeping everyone—from internal teams to regulators—aligned and energized. Who You AreSomeone who can jump into a new environment and take the wheel fast.A natural organizer with top-tier project management and multitasking superpowers.An excellent communicator who can bring clarity to complex topics.Empathetic, collaborative, and adept at navigating a multi-cultural, multi-disciplinary matrix (no small feat).A relationship-builder who can negotiate without friction and keep the goodwill flowing.
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Regulatory Affairs Manager CMC
hace 1 semana
Catalonia, España Oxford Global Resources A tiempo completoOxford Global Resources is seeking a Global CMC Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma company to support headquartered in Barcelona through our consulting services division.Key Responsibilities:Provide CMC regulatory insight and advice to multidisciplinary teams, as well as CMC...
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Quality Regulatory Manager
hace 2 semanas
Catalonia, España elemed A tiempo completoTitle : RAQA Lead - Spain and Portugal Location : Barcelona, Spain Contact : The company Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are always accessible to patients and...
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Quality regulatory manager
hace 6 días
Catalonia, España Elemed A tiempo completoTitle: RAQA Lead - Spain and Portugal Location: Barcelona, Spain Contact: The company Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are always accessible to patients and surgeons...
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Regulatory Compliance Manager
hace 2 semanas
Catalonia, España ARTO A tiempo completoPosition OverviewThe 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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Senior Regulatory Strategist
hace 1 semana
Catalonia, España G&L Scientific A tiempo completoThis role can be based in either our Barcelona, Belfast or London Office. We work on a hybrid basis.Ready to dive into some seriously meaningful science? We're looking for a seasoned CMC Regulatory Affairs pro who loves complex challenges, global coordination, and shaping regulatory strategy for a high-impact vaccine portfolio. You'll step in as our Senior...
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Regulatory Affairs Associate
hace 2 semanas
Catalonia, España Vetpharma A tiempo completoWho we are?Veterinary medicine manufacturersVetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in Barcelona, where the group was founded in 1977.In Vetpharma we are a highly qualified team.We have extensive experience in development, registration and marketing veterinary medicinal...
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Regulatory affairs associate
hace 6 días
Catalonia, España Vetpharma A tiempo completoWho we are? Veterinary medicine manufacturers Vetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in Barcelona, where the group was founded in 1977. In Vetpharma we are a highly qualified team. We have extensive experience in development, registration and marketing veterinary...
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Regulatory Affairs Associate
hace 1 semana
Catalonia, España Vetpharma A tiempo completoWho we are? Veterinary medicine manufacturers Vetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in Barcelona, where the group was founded in 1977. In Vetpharma we are a highly qualified team. We have extensive experience in development, registration and marketing veterinary...
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Trainee - Regulatory Affairs
hace 3 días
Catalonia, España Vetpharma A tiempo completoCONTRATO FORMATIVO PARA LA OBTENCIÓN DE LA PRÁCTICA PROFESIONAL REQUISITOS: HABER FINALIZADO ESTUDIOS EN LOS ÚLTIMOS 3 AÑOS NO HABER TENIDO UN CONTRATO DEL MISMO TIPO CON ANTERIORIDAD Who we are? Veterinary medicine manufacturers Vetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are...
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Trainee - Regulatory Affairs
hace 3 días
Catalonia, España Vetpharma A tiempo completoCONTRATO FORMATIVO PARA LA OBTENCIÓN DE LA PRÁCTICA PROFESIONALREQUISITOS:HABER FINALIZADO ESTUDIOS EN LOS ÚLTIMOS 3 AÑOSNO HABER TENIDO UN CONTRATO DEL MISMO TIPO CON ANTERIORIDADWho we are?Veterinary medicine manufacturersVetpharma is the veterinary division of Chemo, part of the Insud Pharma group, providing Animal Health solutions. We are located in...
