Associate Director, Regulatory Affairs
hace 16 horas
Position SummaryThe Associate Director, CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, and may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Executive Director, CMC Regulatory Affairs.ResponsibilitiesInterpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / BLA/ Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage regulatory dossiers throughout the product development lifecycle.Lead complex programs.Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.Represent CMC regulatory affairs on product teams and in health authority interactions.Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.Support the development and maintenance of regulatory templates, best practices, and procedures.Supervisory ResponsibilitiesSupport hiring, leading workflow and development of staff.Build and lead high-functioning teams.Education and ExperienceExperience of 10+ years with a bachelor's degree in life sciences or 8+ years with a master's degree or 6+ years with PhD.Prior experience in cell/gene therapy.In-depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies.Experience in IND, IMPD, BLA, MAA filings.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.#LI-Hybrid
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Associate Director, Regulatory Affairs
hace 1 mes
España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...
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Regulatory Affairs Associate
hace 2 semanas
España buscojobs España A tiempo completoRegulatory Affairs AssociateBarcelona, CataloniaGalderma - 28.11.2024With 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 approach to dermatological care.Regulatory Affairs AssociateBarcelona, CataloniaGlobal...
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Regulatory Affairs Associate Director
hace 2 semanas
España buscojobs España A tiempo completoAs 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 plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation...
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Regulatory Affairs Associate Director
hace 1 mes
España Sandoz A tiempo completoAs 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 for...
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Regulatory Affairs Associate
hace 1 mes
España Galderma Pharma S.A A tiempo completoRegulatory Affairs Associate 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 fast-growing dermatology...
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Regulatory Affairs Associate
hace 4 semanas
España buscojobs España A tiempo completoGlobal Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in Europe site, we’re searching for a Regulatory Affairs Associate who will manage the relationships with key suppliers and build your own technical specialization...
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España AstraZeneca A tiempo completoAssociate Director of Translational Regulatory ScienceWithin Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients 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...
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Regulatory Affairs Associate
hace 1 mes
España Global Life Science Hub A tiempo completoGlobal Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in Europe site, we’re searching for a Regulatory Affairs Associate who will manage the relationships with key suppliers and build your own technical specialization...
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Senior Regulatory Affairs Director
hace 2 semanas
España buscojobs España A tiempo completoAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
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Senior Regulatory Affairs Director
hace 4 semanas
España AstraZeneca GmbH A tiempo completoAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
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Chemical Regulatory Affairs Associate
hace 1 mes
España W. L. Gore & Associates, Inc A tiempo completoGore Associates, please login to view internal opportunities and refer candidates.Chemical Regulatory Affairs Associate (f/m/d)About the Role: We are looking for a Chemical Regulatory Affairs Associate (f/m/d) to join our Fabrics team. In this role, you will focus on EMEA chemical control regulations enabling the use, development, and movement of chemicals...
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Regulatory Affairs
hace 4 semanas
España CREACIONES AROMATICAS INDUSTRIALES, S.A. A tiempo completoGrupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory Affairs Se responsabilizará de elaborar la documentación técnica relativa a los productos fabricados por la empresa, por lo que deberá conocer la normativa vigente, relacionada con clasificación y envasado de productos químicos....
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España Novartis Farmacéutica A tiempo completoAssociate Director, Business Analyst, DDIT Dev., Regulatory AffairsJob ID REQ-10033825SpainSummaryThis role purpose is to act as a consultant and advisor providing guidance to improve complex global business processes, products, and services. We are looking for an experienced individual in Global Drug Development Regulatory Affairs to lead the business...
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Regulatory Affairs Specialist
hace 1 mes
España Michael Page ES A tiempo completoReporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist will be primarily responsible for:The preparation, submission, monitoring and updating of regulatory dossiers.Prepare high quality regulatory dossiers (novel food, enzymes, GRAS, etc.) needed for the marketing of our products or those of our business partners in different...
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Regulatory Affairs Specialist
hace 1 mes
España Michael Page A tiempo completoMultinational Company | Career development opportunityMultinational company specialized in health supplements and bio ingredients.Reporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist will be primarily responsible for:The preparation, submission, monitoring, and updating of regulatory dossiers.Preparing high-quality regulatory...
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Regulatory Affairs Associate
hace 4 semanas
España Galderma A tiempo completoWith 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 fast-growing dermatology market through Injectable...
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Regulatory Affairs Associate
hace 3 semanas
España Galderma A tiempo completoWith 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 fast-growing dermatology market through Injectable...
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Regulatory Affairs Associate
hace 1 mes
España Galderma A tiempo completoWith 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 fast-growing dermatology market through Injectable...
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Trainee Regulatory Affairs
hace 4 semanas
España Angelini Pharma España A tiempo completoDentro del Departamento de **Regulatory Affairs & QA**, la posición de** Trainee **Regulatory Affairs **está enfocada a dar soporte principalmente el área de Regulatory Affairs en el cumplimiento de los estándares de calidad de los productos comercializados de acuerdo con la normativa vigente a nível nacional y europeo y las directrices establecidas por...
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Regulatory Affairs Junior
hace 4 semanas
España Page Personnel España A tiempo completoTécnico/a para la preparación de la documentación regulatoria de los productos desarrollados por la empresa, complementos alimenticios, productos sanitarios clase IIa, productos sanitarios in vitro y cosméticos. Formación en Ciencias de la Salud|Prácticas en RA y/o Máster en Registros - Formación en Ciencias de la Salud: Farmacia, biología,...