GRA CMC Manager (m/f)

Ort

Bern

Unternehmen

CSL Behring AG

Jetzt per App bewerben

Basisinfos

Unternehmen
CSL Behring AG
Ort
Bern
Funktion
Ärzte
Erfahrung
Mit Berufserfahrung
Sektor
Chemie- & Erdölverarbeitende Industrie, Pharmaindustrie
Anstellungsart
Feste Anstellung
Arbeitszeit
Vollzeit

Aufgabenbeschreibung

  • taking regional regulatory requirements into account
  • Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific Advice Meetings, Briefing Books, IBs)
  • Provision or support of timely and compliant regulatory assessments
  • efficient execution of CMC changes
  • Preparation and review of CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials
  • Regulatory contribution to annual product quality reviews and risk assessments
  • Responsible for strategic CMC regulatory activities related to the assigned products and/or intermediates
  • May represent Global Regulatory Affairs in Core Project Teams for CMC projects
  • development and implementation of global CMC regulatory strategies for product development, clinical trial applications, new license applications, product changes and relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements
  • project planning purposes, compilation and updates of technical documentation and for addressing CMC regulatory questions
  • Evaluates the available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks
  • Supports scheduling and prioritization of CMC related submissions
  • Ensures integration of regional regulatory requirements
  • GRA Strategy Management Review Team (SMRT) or Global Lifecycle Review Board (GLRB)

Detailinfos

Geforderte Fähigkeiten

  • product lifecycle management
  • Operations
  • GRAST
  • risk assessments
  • MS
  • Regulatory Affairs
  • natural sciences
  • biological medicinal products
  • project management
  • Microsoft Office

Geforderte Talente

  • communication
  • problem solving skills
  • presentation skills
  • teamwork
  • organization
  • attention to detail

Sprachen

  • English
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