Suisse 08.10.2021

Senior Regulatory CMC Manager

Tasks

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Scandinavia and Czech Republic.

Senior Regulatory CMC Manager

Your responsibilities include (but are not limited to):

  • Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products
  • Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
  • Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
  • Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders.
  • Lead, prepare and communicate CMC risk management assessments and lessons learned on major submissions

 

Requirements

  • You are allowed to work in Switzerland with your EU or EFTA Passport.
  • You are willing to work onsite in Switzerland.
  • Good understanding of regulatory submission and approval processes (preferably CMC – technical regulatory experience)
  • Good project management, planning, negotiation, organizational and interpersonal skills.
  • Working knowledge / experience in Regulatory Information Management systems or a RIM implementation project
  • Basic understanding or experience with ISO IDMP and structured data submissions is a plus
  • Potential system experience is desirable: Experience in regulatory functions with supporting, developing and deploying IT projects, e.g. Veeva Vault, Liquent solutions, Regulatory Compliance Databases, Agile PLM, SAP S/4Hana, or local systems builds to support information management and compliance, etc.
  • Digital savviness (e.g. basic understanding of analytics, master data, AI, etc.) is a plus
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