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

• 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