Your Role :
Contribute to the 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.
Assist senior colleagues for the global CMC strategy and plan for dossiers related to the assigned projects / products. Examples for these dossier comprise clinical trial applications, answers to Health Authority queries, life cycle management submissions, marketing authorization applications, briefing documentation for Health Authority interactions.
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 to track submission and approval status to ensure regulatory compliance for all CMC dossier submissions worldwide.
Maintain knowledge of regulatory environment within the CMC regulatory area current. Support development and execute initiatives to ensure regulatory compliance as required
Who you are :