Cmc Regulatory Affairs Associate Director Biologics |
hace 2 meses
CMC Regulatory Affairs Associate Director BiologicsLocation - BarcelonaCompetitive salary and benefits packageIntroduction to roleJoin our dynamic team at AstraZeneca as a CMC Regulatory Affairs Associate Director. Based in our Barcelona, Spain hub, you will be a core member of our cross-functional Regulatory Strategy, Biopharmaceutical and Global Supply Teams. This role is an opportunity to support the biologics technical area, encompassing both traditional and novel molecules. We pride ourselves on our encouraging culture and cross-project knowledge sharing. Are you ready to unlock knowledge and learning opportunities with us?AccountabilitiesAs a CMC Regulatory Affairs Associate Director, your responsibilities will include:Devising creative strategies to support a range of new biologics and novel products, from development to post-approval lifecycle management.Providing strategic, tactical, and operational expertise and direction to AstraZeneca project teams.Handling high-level risk and supporting project-driven regulatory interactions with health authorities.Leading and/or delivering CMC Regulatory components of business process improvement projects.Sharing your knowledge actively within CMC RA and the wider business.Essential Skills/Experience:Bachelor's degree or equivalent experience in a science or technical field such as pharmacy, biology, chemistry, or biological science.Significant experience of working in one or more areas in regulatory affairs in the biopharmaceutical industry, or in regulatory drug development, product approval/launch, line extension, and license maintenance, or experience at a health authority.Project and process management skills.Desirable Skills/Experience:Advanced degree or equivalent experience in a science or technical field such as pharmacy, biology, chemistry, or biological science.Regulatory experience across global projects and several regions for antibody drug conjugates, radioconjugates, or bispecifics.At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We are all compassionate team players and driven achievers, always ready to step up. We're motivated by science, success, and achieving our goals in a way that's novel and thoughtful.#J-18808-Ljbffr
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Cmc Regulatory Affairs Director Biologics
hace 1 mes
Barcelona, España Astrazeneca A tiempo completo.CMC Regulatory Affairs Director BiologicsLocation: Barcelona, Spain (we require 3 days working from the office and 2 days working from home)Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development,...
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Cmc Regulatory Affairs Director Biologics
hace 1 mes
Barcelona, España Astrazeneca A tiempo completoCMC Regulatory Affairs Director BiologicsLocation: Barcelona, Spain (we require 3 days working from the office and 2 days working from home) Our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development,...
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Cmc Regulatory Affairs Associate Director
hace 2 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home** Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of...
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Cmc Regulatory Affairs Associate Director Biologics
hace 2 meses
Barcelona, España AstraZeneca A tiempo completo**CMC Regulatory Affairs Associate Director Biologics** **Location - Barcelona** **Competitive salary and benefits package** **Introduction to role** Join our dynamic team at AstraZeneca as a CMC Regulatory Affairs Associate Director. Based in our Barcelona, Spain hub, you will be a core member of our cross-functional Regulatory Strategy,...
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CMC Regulatory Affairs Associate Director
hace 1 mes
Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completoJob Title: CMC Regulatory Affairs Associate DirectorAbout the Role: We are seeking a highly skilled CMC Regulatory Affairs Associate Director to join our dynamic team in Barcelona, Spain. As a key member of our cross-functional Regulatory Strategy, Pharmaceutical, and Global Supply Teams, you will collaborate with colleagues across the globe to ensure...
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Regulatory Affairs Associate Director for CMC Specialists
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Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Associate Director to join our CMC team in Barcelona, Spain.Key Responsibilities* Provide strategic, tactical, and operational expertise to project teams* Develop creative strategies to support new biological entities and novel products* Collaborate with cross-functional teams to ensure...
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CMC Regulatory Affairs Associate Director
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Barcelona, Barcelona, España Az Farmacéutica Spain S.A A tiempo completoJob SummaryAt Az Farmacéutica Spain S.A, we are seeking a highly skilled CMC Regulatory Affairs Associate Director to join our dynamic team in Barcelona, Spain. As a key member of our Regulatory Strategy, Pharmaceutical, and Global Supply Teams, you will play a crucial role in delivering expert CMC regulatory input for projects spanning across the product...
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hace 1 mes
Barcelona, Barcelona, España Galderma A tiempo completoWe are seeking an expert in Regulatory Affairs to join our team at Galderma. As a Regulatory Affairs CMC Specialist, you will be responsible for preparing and updating the CMC dossier sections of assigned products. This includes assessing regulatory impact, reviewing data, and writing/ assembling CMC sections of regulatory submissions.Key responsibilities...
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Barcelona, Barcelona, España Galderma A tiempo completoAbout the RoleWe are seeking an experienced Regulatory Affairs Specialist to join our team in preparing and updating CMC dossier sections for assigned products. As a key member of our Regulatory Affairs team, you will contribute to the development of RA-CMC strategies for geographical extension and post-approval CMC activities.Key ResponsibilitiesContribute...
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International Cmc Regulatory Affairs Director
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Barcelona, España AstraZeneca A tiempo completo**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 to make the impossible a reality. 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...
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Barcelona, España Mcr International A tiempo completoMFC-2409-303 REGULATORY AFFAIRS CMC SPECIALIST BARCELONA Desde MCR International , nos encontramos colaborando con una importante compañía farmacéutica en la búsqueda de un Técnico de Regulatory Affairs CMC .Funciones: Dar soporte regulatorio en los desarrollos de medicamentos de la compañía.Preparar la documentación necesaria.Gestionar la...
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Barcelona, España Sandoz A tiempo completo.As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation...
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Regulatory Affairs Cmc Specialist
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Barcelona, España Mcr International A tiempo completoMFC-2409-303REGULATORY AFFAIRS CMC SPECIALISTBARCELONADesde MCR International , nos encontramos colaborando con una importante compañía farmacéutica en la búsqueda de un Técnico de Regulatory Affairs CMC .Funciones:Dar soporte regulatorio en los desarrollos de medicamentos de la compañía.Preparar la documentación necesaria.Gestionar la interlocución...
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