Senior Manager/Director of Regulatory Affairs
hace 1 semana
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 method Implementing new potency reference vaccine replacements If leading cross-functional teams, navigating global health authorities, and crafting impeccable regulatory dossiers sounds like your kind of adventure, read on. # ; Education ~ Master’s degree or higher in chemistry, pharmacy, biology, or similar (we’ll be extra impressed if you have a PhD ). # ; What You Bring ~8+ years in CMC Regulatory Affairs—bonus points if you’ve wrangled global lifecycle submissions for vaccines. ~ Hands-on experience with: ~ Registering new analytical methods ~ Potency assay development and validation ~ Reference standard strategy and maintenance ~ A 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 Are Someone 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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Senior Regulatory Affairs Director
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completoAre you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working...
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Senior Regulatory Affairs Director
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Barcelona, España AstraZeneca A tiempo completoAre you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on!About AstraZeneca At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together...
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Technical/regulatory Affairs Manager
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Barcelona, España Page Personnel España A tiempo completoMaintain up-to-date and follow all Company Quality Assurance System ensuring alignment with regulatory requirements as per Quality Standard EN ISO 13485:2016, the Medical Device Directive 93/42/EEC and new Regulation (EU) 2017/745 requirements - Manage the EC Certificates, the EN ISO 13485 Certificate and the Manufacturer License issued by NB 0318-AEMPS...
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Regulatory Affairs Manager
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Barcelona, España Jordan martorell s.l. A tiempo completoJob Title:¿Tiene las habilidades necesarias para este puesto? Lea todos los detalles a continuación y presente su candidatura hoy mismo.European Regulatory Affairs ManagerLocation:Madrid, Spain - HybridRemuneration:Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in...
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Senior Regulatory Affairs Manager
hace 7 días
barcelona, España JR Spain A tiempo completoA leading health consultancy in Barcelona is seeking a Regulatory Affairs Senior Manager. This full-time role involves developing client relationships, managing regulatory processes for medicinal products, and providing strategic guidance. The ideal candidate has a degree in Life Science and experience in regulatory affairs, with excellent communication...
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Director of Regulatory Affairs
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Barcelona, 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.Provide CMC regulatory insight and advice to multidisciplinary teams, as well as CMC technical functions on...
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Senior Regulatory Affairs Manager
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Barcelona, España AstraZeneca A tiempo completoAre you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Oncology Regulatory Science and Strategy Within Oncology...
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Regulatory Affairs Director
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Barcelona, España AstraZeneca A tiempo completoAt AstraZeneca, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology...
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Eu Regulatory Affairs Director/senior Regulatory
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completo**Are you a strategically focused Regulatory Affairs professional and would like to play a central role in crafting innovative drug development strategies and gaining fast, efficient regulatory approvals? If so, read on...** **At AstraZeneca, we work with a diverse set of minds, all united by a shared passion to learn, grow and discover**. **Who we...
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Scientific & Regulatory Affairs Manager
hace 7 días
barcelona, España JR Spain A tiempo completoSocial network you want to login/join with: Regulatory Affairs Senior Manager, Barcelona Client: Cencora Location: Barcelona, Spain Job Category: Other EU work permit required: Yes Job Reference: Job Views: 1 Posted: Expiry Date: Job Description: Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create...
