Associate Director, Regulatory Affairs

hace 2 días


Barcelona, España Astrazeneca Gmbh A tiempo completo

Position Summary The 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.
Responsibilities Interpret 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 Responsibilities Support hiring, leading workflow and development of staff.Build and lead high-functioning teams.Education and Experience Experience 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

#J-18808-Ljbffr



  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    Job Title: Associate Regulatory Affairs Director ICareer Level - EIntroduction to Role:Join our Oncology R&D team as an Associate Regulatory Affairs Director I. This role is perfect for an experienced regulatory specialist with strong project management capabilities. You will be responsible for leading the end-to-end planning, coordination, and execution of...


  • 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...


  • Barcelona, España buscojobs España A tiempo completo

    Regulatory 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...


  • Barcelona, España buscojobs España A tiempo completo

    Regulatory 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...


  • 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...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    Position Summary The 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....


  • Palafolls, Barcelona provincia, 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 for...


  • 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,...


  • Barcelona, España buscojobs España 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 plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation...


  • Barcelona, España buscojobs España 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 plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation...


  • Barcelona, España buscojobs España 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 plans. This includes preparation of registration documentation and assessment of appropriateness of registration documentation...


  • 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 for...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    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...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    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...


  • Barcelona, España AstraZeneca GmbH A tiempo completo

    Position Summary The 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....


  • Barcelona, España AstraZeneca A tiempo completo

    Welcome 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...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    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...


  • Barcelona, España Galderma Pharma S.A A tiempo completo

    .Regulatory 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...


  • Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona (on-site)** Within 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 work across our...


  • Barcelona, España Argenta A tiempo completo

    **Who are we?** **The Opportunity** Due to continued growth we are looking to recruit a Regulatory Affairs Associate (specifically for feed) to join our consultancy. You will get the opportunity to work alongside our experienced team on a variety of challenging and innovative projects within the animal nutrition sector. Day to day you will manage our...