Cmc Reg Consultant

The Regulatory CMC Department of our client is looking for a Lifecycle CMC Reg Consultant.Mission:Responsible for delivery of specific post-approval activities (EU, USA or ROW) for a commercial Biopharm asset.Activities and responsibilities:Write, review and compile (as needed) all regulatory documents in support of each submission on time and in line with country requirements (including EU, USA and ROW)Contribute to the CMC Regulatory strategy for all post-approval activities of the asset, providing proactive and timely advice to the Technical teamManage and deliver regulatory aspects related to Change Control requestsDeliver project management activities to support the CMC post-approval work of the asset to ensure the necessary regulatory documents are delivered in time and with the right qualityLiaise with the Local Affiliates of the respective countries to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelinesGenerate gap analysis and risk management support for each submission as neededIdentify rate limiting deliverables and interdependencies across the technical and regulatory aspects of the different submissionsProvide status updates to all stakeholders as neededManagement of all documents through the document management system.Profile/Experience:Extensive (at least 10 years) experience in managing the delivery of post-approval CMC Regulatory activities for Biopharm assets globally.Organized and independentAbility to manage multiple activities concomitantlyDegree in a relevant science/technical subjectFluent in English