Cmc Regulatory Affairs Director Biologics
hace 1 mes
.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, manufacturing and testing of all our medicines. With our expertise we interpret, anticipate and craft global Health Authority expectations to build CMC and Device Regulatory Strategies.We are seeking a CMC Regulatory Affairs Associate Director to add to our dynamic team in our Barcelona, Spain hub. This role will support the biologics technical area, encompassing both traditional and novel molecules.CMC Regulatory Affairs Associate Directors are a core member of our cross-functional Regulatory Strategy, Pharmaceutical and Global Supply Teams. Working in partnership with the technical functions, CMC Associate Directors collaborate with colleagues in AZ marketing companies across the globe to ensure successful regulatory outcomes for clinical trials, marketing applications and complex post approval changes to meet the needs of our patients and the business. We pride ourselves on our encouraging culture and cross-project knowledge sharing.As a CMC Regulatory Affairs Associate Director 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.Provide strategic, tactical and operational expertise and direction to AstraZeneca project teams, based on understanding of global CMC regulations.Handle high level risk by making sophisticated judgments, developing innovative solutions, and applying comprehensive cross-functional and industry understanding.Have a high level of interactive social skills and cultural sensitivity which you will use to advise CMC teams on how to achieve successful regulatory outcomes.Lead project driven regulatory interactions with health authorities, e.G. FDA, EMA, for CMC scientific advice.Lead and/or deliver CMC Regulatory components of business process improvement projects.Ensure the application of global CMC regulations and guidance within AstraZeneca and lead development of new guidance.Share your knowledge actively within CMC RA and the wider business, participate in the coaching and mentoring of colleagues and keep up to date with emerging global regulatory requirements.You may also be asked to support due diligence reviews.Minimum Qualifications:Bachelor's degree 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
-
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,...
-
Barcelona, España Astrazeneca A tiempo completoCMC 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...
-
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...
-
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,...
-
CMC Regulatory Affairs Associate Director
hace 4 semanas
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...
-
Regulatory Affairs Associate Director for CMC Specialists
hace 2 semanas
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...
-
Regulatory Affairs CMC Specialist
hace 3 semanas
Barcelona, Barcelona, España Galderma A tiempo completoJob Title: Regulatory Affairs CMC SpecialistJob Description:We are seeking an experienced Regulatory Affairs CMC Specialist to join our team at Galderma. As a key member of our regulatory affairs team, you will be responsible for preparing and updating CMC (Chemistry, Manufacturing, and Control) dossier sections for assigned products.Key Responsibilities:•...
-
CMC Regulatory Affairs Associate Director
hace 4 semanas
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...
-
Regulatory Affairs CMC Specialist
hace 1 mes
Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completoAbout GaldermaWe are a leading dermatology company with a unique legacy and decades of innovation. Our focus is on advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning, and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be...
-
Galderma CMC Regulatory Affairs Expert
hace 4 semanas
Barcelona, Barcelona, España Galderma A tiempo completoCompany OverviewGalderma is a leading dermatology category leader, operating in approximately 90 countries worldwide. Our innovative, science-based portfolio of premium flagship brands and services spans the full spectrum of the fast-growing dermatology market, including Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology.We have dedicated...
-
Regulatory Affairs CMC Specialist
hace 4 semanas
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...
-
Regulatory Affairs Specialist
hace 1 mes
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...
-
Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Galderma A tiempo completoJob Title: Regulatory Affairs CMC SpecialistWe are seeking an experienced 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.Key Responsibilities:Contribute to global regulatory CMC strategies and...
-
International Cmc Regulatory Affairs Director
hace 7 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...
-
Regulatory Affairs Cmc Specialist
hace 2 meses
Barcelona, España Mcr International A tiempo completoMFC-2409-303REGULATORY AFFAIRS CMC SPECIALISTBARCELONA 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...
-
Regulatory Affairs Cmc Specialist
hace 2 meses
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...
-
International Cmc Regulatory Affairs Director
hace 7 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,...
-
Regulatory Affairs Cmc Specialist
hace 2 meses
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...
-
Regulatory Affairs Cmc Specialist
hace 4 semanas
Barcelona, España Mcr International A tiempo completoMFC-2409-303REGULATORY AFFAIRS CMC SPECIALISTBARCELONADesde MCR International, nos encontramos colaborando con unaimportante compañía farmacéuticaen la búsqueda de unTécnico de Regulatory Affairs CMC .Funciones:Dar soporte regulatorio en los desarrollos de medicamentos de la compañía.Preparar la documentación necesaria.Gestionar la interlocución con...
-
Regulatory Affairs Specialist
hace 4 semanas
Barcelona, Barcelona, España Galderma A tiempo completoWe are seeking an expert in Regulatory Affairs to join our team at Galderma. This role will focus on preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products.The ideal candidate will have experience in CMC Regulatory Affairs and a background in the pharmaceutical industry. They will be responsible for...