Kim Weber

Associate Director, Regulatory Affairs EMEA at Ultragenyx

Switzerland

About

Experience

  • Associate Director, Regulatory Affairs EMEA at Ultragenyx
    Sep 2025 - Present · 10 mos

  • BerGenBio ASA (4 yrs 6 mos)
    • Associate Director, Global Regulatory Affairs
      Jul 2023 - Jun 2025 · 2 yrs

    • Senior Manager, Global Regulatory Affairs
      Jan 2022 - Jun 2023 · 1 yr 6 mos

    • Manager, Global Regulatory Affairs
      Jan 2021 - Dec 2021 · 1 yr

  • Celgene (3 yrs 9 mos)
    • Associate Manager, EU Regulatory Affairs
      Apr 2019 - Dec 2020 · 1 yr 9 mos

      • submission of MAA for an orphan biological product • responsible for orphan activities: orphan designation applications, maintenance reports & annual reports • responsible for paediatric activities: PIP modifications, request for waiver and compliance check • CHMP scientific advice

    • Senior Specialist, EU Regulatory Affairs
      Apr 2017 - Apr 2019 · 2 yrs 1 mo

      • managed EU CTAs : review of protocols & investigator’s brochures, preparation of core packages, DSUR submission

  • Amgen (1 yr 3 mos)
    • Regulatory Affairs Senior Associate-Intercontinental Region
      Jul 2016 - Mar 2017 · 9 mos

      • responsible for lifecycle activities for a biologic product • managed CTAs for an ATMP for the Intercontinental region • developed the regulatory strategy for an early stage oncology product

    • Regulatory Affairs Associate-Intercontinental Region
      Jan 2016 - Jul 2016 · 7 mos

      • submitted MAAs, variations and renewals for the Intercontinental region

  • Global Regulatory Strategy intern at Bayer
    Mar 2015 - Dec 2015 · 10 mos

    • prepared end of phase 2 & advisory committee meetings with FDA • led preparation of a global regulatory plan: strategic assessment for development across regions • conducted a gap analysis on drug/device combination products and created a tool to address internal gaps