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Manager CMC Regulatory - Biologics (m/f) Job ID: 10561

Regulatory Affairs
Ihre Aufgaben
  • Lead the CMC regulatory affairs function and develop and implement regulatory CMC strategy, fulfilling regulatory requirements of worldwide regulatory bodies (ICH and non-ICH countries), resulting in timely registration of our pipeline

  • Develop, communicate, and implement global CMC regulatory strategies in support of our goals and internal/client product portfolio execution

  • Ensure CMC documents for briefing books, CTAs, MAAs/BLAs, manufacturing amendments, and other documents as required, are developed with high quality and delivered in a timely manner

  • Lead cross-functional teams in development and submission of high quality documents, including responses to questions from regulatory authorities

  • Maintain product licenses per regulatory requirements and updated according to long-term plans

  • Deliver CMC information for submissions (including Module 3, analytical similarity assessments)

  • Prepare for and participate in CMC-related agency interactions

  • Represent CMC RA on the development teams

  • Collaborate with other development functions, e.g. Technical Development, Production, QA, Regulatory Strategy and device development teams

  • Involved into change control assessment and evaluation

  • Comply with company CMC and GDevP processes

  • Participate in vendor oversight and management for regulatory CMC operations, as required

  • Provide regulatory risk assessment to the Biologics development functions and to CMC filing teams

  • Escalate CMC issues, progress, and metrics to the regulatory, development and production leadership

  • Ensure flow of information is tracked and actively monitors progress identifying issues for resolution

  • Assure correct document formatting according regulatory requirements as well as filing and archiving of documentation

Auf Anfrage
Auf Anfrage
Larissa Weber
Fon +49 89 416 117 0 – 0
Mobil + 49 152 295 555 62
Larissa Weber
Fon +49 89 416 117 0 – 0
Mobile + 49 152 295 555 62
Mail larissa.weber@theentourage.de
Betreff Bewerbung für Job ID 10561 auf theentourage.de