Lifecycle CMC Reg Consultant

Mission:

To manage the post-approval Regulatory CMC activities across all global markets.

Activities and responsibilities:

-Execute the CMC Regulatory strategy for all post-approval activities of the asset, providing proactive and timely advice to the Technical team.

-Manage and deliver all regulatory aspects related to Change Control requests

-Lead and deliver all 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

-Represent CMC Regulatory across the relevant governance meetings and activities

-Write, review and compile (as needed) all regulatory documents in support of each submission on time and in line with country requirements

-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

In addition to this, and depending on the actual need of the activities described above, the following activities will be part of the tasks associated with this role:

– Supports theCMC Technical team on any other tasks associated with the delivery of regulatory documentation.

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