Cmc Regulatory Affairs Director Biologics
hace 3 días
.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/ExperienceAdvanced 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 bispecificsWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.At AstraZeneca's Biopharmaceuticals R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world
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Cmc Regulatory Affairs Director Biologics
hace 3 días
Barcelona, España Astrazeneca Gmbh A tiempo completoCMC Regulatory Affairs Director Biologics Location - Barcelona Competitive salary and benefits package Introduction 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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Cmc Regulatory Affairs Director Biologics
hace 3 días
Barcelona, España Astrazeneca Gmbh 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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Cmc Expert
hace 4 semanas
Barcelona, España Asphalion Ltd A tiempo completoRegulatory Affairs · Barcelona · Fully Remote CMC Expert (Biologics) Do you want to join us as CMC Expert and boost your skills in a Global technical environment? Are you willing to contribute, learn and develop? Do you want to apply your knowledge in health sciences and RA in a dynamic and international team? Main responsibilities: • CMC project...
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Cmc Expert
hace 1 semana
Barcelona, España Asphalion Ltd A tiempo completoRegulatory Affairs · Barcelona · Fully RemoteCMC Expert (Biologics) Do you want to join us as CMC Expert and boost your skills in a Global technical environment? Are you willing to contribute, learn and develop? Do you want to apply your knowledge in health sciences and RA in a dynamic and international team?Main responsibilities:• CMC project...
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International Cmc Regulatory Affairs Director
hace 2 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 2 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 Associate Director
hace 2 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, big dreamers, and collaborators who work 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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Cmc Expert
hace 3 semanas
Barcelona, España Asphalion A tiempo completo**Main responsibilities**: - CMC project lead/responsible person, reporting to CMC Director. - Overall CMC writing/management of product-specific dossiers (Mod. 2/Mod. 3), including, but not limited to, new registration packages, variation packages and renewal packages in the EU, US and RoW markets. - High-quality strategic support to CMC roadmaps, dossier...
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Cmc Expert
hace 2 semanas
Barcelona, Barcelona, España Asphalion Ltd A tiempo completoRegulatory Affairs · Barcelona · Fully Remote CMC Expert (Biologics) Do you want to join us as CMC Expert and boost your skills in a Global technical environment? Are you willing to contribute, learn and develop? Do you want to apply your knowledge in health sciences and RA in a dynamic and international team?Main responsibilities: CMC project...
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RA-CMC Specialist
hace 2 semanas
Barcelona, Barcelona, España Galderma A tiempo completoDescription We are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (Rx or non-monograph OTC drugs). This person will contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities. Key Responsibilities ...
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RA-CMC Specialist
hace 2 meses
Barcelona, España Galderma A tiempo completoDescription We are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (Rx or non-monograph OTC drugs). This person will contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities. Key Responsibilities...
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Regulatory Affairs Director
hace 3 semanas
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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International Cmc Regulatory Affairs Manager
hace 2 meses
Barcelona, España AstraZeneca A tiempo completo**Job Description**: **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...
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Regulatory Affairs Director
hace 3 semanas
Barcelona, España Consult Search A tiempo completo**Scope**: Director of regulatory affairs position that has been opened to further accompany the growth of the company on this sector. Although our client is a historically pharma oriented manufacturer, they have in the recent years expanded their activities in the Medical Aesthetics area, with products currently on market in the Dermal and Hyaluronic acid...
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Regulatory Affairs Director
hace 2 semanas
Barcelona, 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 onAt 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...
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Regulatory Affairs Director
hace 6 días
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! 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...
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Barcelona, España AstraZeneca A tiempo completoDo you have leadership skills and an in depth knowledge within **Regulatory Affairs? **Do you want to work on **innovative projects** of importance for our early Respiratory and Immunology portfolio? At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas and truly transform patient outcomes. This means our people are here to win,...
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International Cmc Regulatory Affairs Associate
hace 2 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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Regulatory Affairs Manager
hace 2 meses
Barcelona, España AstraZeneca A tiempo completoAt AstraZeneca, we're not just about treating diseases - we're about defeating them. We're on a mission to turn innovative science into life-changing medicines, and we need your help. As a Reg Affairs Manager in our Oncology R&D department, you'll play a crucial role in gaining approval for our novel work on unmet medical needs. If you're ready to make a...
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Ra-Cmc Specialist
hace 3 semanas
Barcelona, España Knewin A tiempo completoRA-CMC Specialist Barcelona Barcelona, Catalonia, ES With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the...
