CMC Reg Consultant
il y a 2 semaines
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 team
- Manage and deliver regulatory aspects related to Change Control requests
- Deliver 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 quality
- Liaise 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 timelines
- Generate gap analysis and risk management support for each submission as needed
- Identify rate limiting deliverables and interdependencies across the technical and regulatory aspects of the different submissions
- Provide status updates to all stakeholders as needed
- Management 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 independent
- Ability to manage multiple activities concomitantly
- Degree in a relevant science/technical subject
- Fluent in English
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Essonne (91), France Ividata Life Sciences Temps pleinThe 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...
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Essonne (91), France Ividata Life Sciences Temps pleinThe 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...
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