Cmc Regulatory Affairs Director Biologics
hace 4 semanas
CMC Regulatory Affairs Director BiologicsLocation - BarcelonaCompetitive salary and benefits packageIntroduction to role:Join our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team in Barcelona, Spain, where we deliver expert CMC regulatory input for projects across the product lifecycle. As a CMC Regulatory Affairs Director, you will support the biologics technical area, encompassing both traditional and novel molecules. You will be a core member of our cross-functional Regulatory Strategy, Pharmaceutical and Global Supply Teams, collaborating with colleagues across the globe to ensure successful regulatory outcomes for clinical trials, marketing applications and complex post approval changes.Accountabilities:In this role, you will use your regulatory experience to devise creative strategies to support a range of new biological entities and novel products, from development to post approval lifecycle management. You will provide strategic, tactical and operational expertise to AstraZeneca project teams, handle high level risk by making sophisticated judgments, and develop innovative solutions. You will lead project driven regulatory interactions with health authorities, such as FDA and EMA, for CMC scientific advice. You will also be asked to support due diligence reviews.Essential Skills/Experience:Bachelor's degree or equivalent experience in a science or technical field such as pharmacy, biology, chemistry or biological scienceBreadth of knowledge of manufacturing, project, technical and regulatory project managementStrong understanding of regulatory affairs globally, particularly with respect to the CMC fieldRegulatory Affairs CMC experience with submissions for biologics drug substances and products.Desirable Skills/Experience:Advanced degree or equivalent experience in a science or technical field such as pharmacy, biology, chemistry or biological scienceRegulatory Affairs CMC experience with submissions for antibody drug conjugates, radioconjugates or bispecificsReady to make a meaningful impact on patients' lives? Apply now and strengthen our pipeline to help more patients and grow our area.We encourage your application by the 11th June 2024.#J-18808-Ljbffr
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(T-286) | Cmc Regulatory Affairs Director Biologics
hace 4 semanas
Barcelona, España Az Farmacéutica Spain S.A A tiempo completoCMC Regulatory Affairs Director BiologicsLocation: BarcelonaCompetitive salary and benefits packageIntroduction to Role:Join our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team in Barcelona, Spain, where we deliver expert CMC regulatory input for projects across the product lifecycle. As a CMC Regulatory Affairs Director, you will...
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Regulatory Affairs CMC Specialist
hace 8 horas
Barcelona, Barcelona, España Galderma A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs CMC Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products, contributing to global regulatory CMC strategies, and ensuring compliance with regulatory...
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Regulatory Affairs CMC Specialist
hace 23 horas
Barcelona, Barcelona, España Galderma A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs CMC Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products, contributing to global regulatory CMC strategies, and ensuring compliance with regulatory...
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Regulatory Affairs CMC Expert
hace 4 semanas
Barcelona, Barcelona, España Galderma A tiempo completoPosition Overview We are seeking a knowledgeable professional in Regulatory Affairs to prepare and enhance the CMC (Chemistry, Manufacturing and Control) documentation for assigned products, including prescription and non-monograph OTC medications. This role will play a crucial part in developing regulatory CMC strategies for geographical expansion and...
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Regulatory Affairs CMC Expert
hace 6 días
Barcelona, Barcelona, España Galderma A tiempo completoPosition Overview We are seeking a knowledgeable professional in Regulatory Affairs to prepare and enhance the CMC (Chemistry, Manufacturing and Control) documentation for assigned products, including prescription and non-monograph OTC medications. This role will play a crucial part in developing regulatory CMC strategies for geographical expansion and...
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Regulatory Affairs CMC Expert
hace 4 semanas
Barcelona, Barcelona, España Galderma A tiempo completoPosition Overview We are seeking a highly skilled professional in Regulatory Affairs to manage and enhance the CMC (Chemistry, Manufacturing and Control) documentation for designated products, including prescription and non-monograph over-the-counter medications. This role will involve developing strategic regulatory CMC approaches for market expansion...
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Regulatory Affairs CMC Expert
hace 6 días
Barcelona, Barcelona, España Galderma A tiempo completoPosition Overview We are seeking a highly skilled professional in Regulatory Affairs to manage and enhance the CMC (Chemistry, Manufacturing and Control) documentation for designated products, including prescription and non-monograph over-the-counter medications. This role will involve developing strategic regulatory CMC approaches for market expansion...
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Regulatory Affairs CMC Expert
hace 6 días
Barcelona, Barcelona, España Galderma A tiempo completoPosition Overview We are seeking a highly skilled professional in Regulatory Affairs to manage and enhance the CMC (Chemistry, Manufacturing and Control) documentation for designated products, including prescription and non-monograph over-the-counter medications. This role involves the development of strategic regulatory CMC plans aimed at geographical...
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Regulatory Affairs CMC Expert
hace 4 semanas
Barcelona, Barcelona, España Galderma A tiempo completoPosition Overview We are seeking a highly skilled professional in Regulatory Affairs to manage and enhance the CMC (Chemistry, Manufacturing and Control) documentation for designated products, including prescription and non-monograph over-the-counter medications. This role involves the development of strategic regulatory CMC plans aimed at geographical...
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Regulatory Affairs Specialist
hace 4 días
Barcelona, Barcelona, España Galderma A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist - CMC to join our team at Galderma. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our CMC (Chemistry, Manufacturing, and Control) dossier sections for our assigned products.Key ResponsibilitiesContribute to the...
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Regulatory Affairs Specialist
hace 4 días
Barcelona, Barcelona, España Galderma A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist - CMC to join our team at Galderma. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our CMC (Chemistry, Manufacturing, and Control) dossier sections for our assigned products.Key ResponsibilitiesContribute to the...
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Regulatory Affairs Specialist
hace 3 días
Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completoAbout GaldermaGalderma Pharma S.A. is a leading global dermatology company dedicated to advancing the science of dermatology. With a rich legacy in the field, we have established ourselves as a pure-play dermatology category leader, present in approximately 100 countries. Our innovative, science-based portfolio of premium brands and services spans the full...
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Regulatory Affairs Specialist
hace 3 días
Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completoAbout GaldermaGalderma Pharma S.A. is a leading global dermatology company dedicated to advancing the science of dermatology. With a rich legacy in the field, we have established ourselves as a pure-play dermatology category leader, present in approximately 100 countries. Our innovative, science-based portfolio of premium brands and services spans the full...
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Regulatory Affairs Specialist
hace 21 horas
Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completoAbout Galderma Pharma S.A.We are a leading pharmaceutical company dedicated to advancing dermatology for every skin story. With a unique legacy in dermatology and decades of cutting-edge innovation, we deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market.Our...
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Regulatory Affairs Specialist
hace 23 horas
Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completoAbout Galderma Pharma S.A.We are a leading pharmaceutical company dedicated to advancing dermatology for every skin story. With a unique legacy in dermatology and decades of cutting-edge innovation, we deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market.Our...
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International Cmc Regulatory Affairs Director
hace 5 meses
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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International Cmc Regulatory Affairs Director
hace 4 meses
Barcelona, España AstraZeneca A tiempo completoWelcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, working together to turn the impossible into reality. If you are action-oriented, confident in leadership, collaborative, and curious about the potential of science, then you are the perfect fit for us. Join our Chemistry,...
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Regulatory Affairs Specialist
hace 6 días
Barcelona, Barcelona, España Galderma A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products.Key ResponsibilitiesContribute to global regulatory CMC...
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Regulatory Affairs Specialist
hace 5 días
Barcelona, Barcelona, España Galderma A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products.Key ResponsibilitiesContribute to global regulatory CMC...
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International Cmc Regulatory Affairs Director
hace 4 semanas
Barcelona, España Astrazeneca A tiempo completoWelcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, working together to turn the impossible into reality. If you are action-oriented, confident in leadership, collaborative, and curious about the potential of science, then you are the perfect fit for us.Join our Chemistry,...
