Job Ref: 214484886

Date: 2021-08-20 15:46:12

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The Project Director is an experienced regulatory project management professional who has detailed knowledge and experience of the centralised procedure which will enable them to proactively plan timelines and activities with minimal input from the EU regulatory lead and to maintain oversight of the status of key deliverables.

Daily activities will include:

* Project management of all post-submission MAA activities, including detailed project management of clinical responses and overall coordination of all responses across modules (detailed project plan, timelines, milestones, etc).

* Collate clinical questions (at Day 80, 120, 150 and 180) into a spreadsheet and track response status, timelines and progress.

* Perform a detailed analysis of LoQ/LoOI identifying overlaps with draft questions, new and removed questions (Day 120 and Day180).

* Define full content of response sequences including new reports and updated modules (Day 120 and Day 180).

* Interface with Client Reg Ops to ensure timely handover of final documents for publishing.

* Attend team meetings (as required).

* Prepare quarterly budget review

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