Job Ref: 213261992

Date: 2021-02-27 09:46:28

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An Associate, Regulatory Sciences will provide support for regulatory submissions and post authorisation in line with agreed client strategy. Additionally, an Associate, Regulatory Sciences will collect data relevant to essential regulatory questions, issues or problems and will identify factors leading to regulatory recommendations.

Essential Functions Include:

* Provide support on a range of regulatory submissions, including but not limited to: MAA submissions, Orphan applications, PIPs, Accelerated Assessment and Conditional approval requests

* Support preparation for EMEA submissions

* Co-author basic regulatory documents

* Data collection and integration

* Briefing of clients and internal project teams

* Attend client meetings and conducting client liaison as required

* Provide scientific support for new business pitches and proposals

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