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Senior Manager Global Regulatory Affairs CMC - Biologocs

Your role: Lead and drive global CMC regulatory strategy for the assigned products in target regions. This encompasses responsibility for the CMC section of the Regulatory Strategy Document, risk assessment, strategic support and advice. Provide support to the GRL/MPL during Health Authority interactions on CMC issues. Be accountable for the global strategy and plan for dossiers related to the assigned projects. Examples for these dossiers comprise clinical trial applications, answers to Health Authority queries, life cycle management submissions, marketing authorization applications, briefing documentation for Health Authority interactions. Be accountable and responsible to provide country specific CMC regulatory requirements for dossier strategies and plans in close collaboration with other GRA functions. This includes assessment of Change Control Proposals for their regulatory impact worldwide to ensure that for each change control proposal, the regulatory implications have been considered. Review study protocols and reports, as well as other relevant technical documents intended for the product documentation platform or for local submission to confirm alignment of the report conclusions with the CMC Dossier Strategy and Plan. Be accountable for CMC dossier approval. Be accountable to track submission and approval status to ensure regulatory compliance for all CMC dossier submissions worldwide.

 

Who you are 

  • Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
  • 7 years of pharmaceutical industry experience, with at least 3 years of global CMC regulatory experience
  • Ability to develop and prepare successful regulatory strategies and dossiers
  • In-depth knowledge of global pharmaceutical legislation
  • Excellent written and spoken communication skills in English
Job Requisition ID:  186527
Location:  Aubonne
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


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