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DATE ADDED: Thu 27/06/2019

Regulatory Affairs Manager

Edinburgh, UK
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JOB TYPE: Permanent

Entrust People are looking for a Regulatory Affairs Manager to join an exciting biotech pharmaceutical company who are fully focussed on oncology. This role is permanent, full time and based at their Edinburgh premises.

This role is a brand new opportunity with a fantastic organisation that is looking for an experienced Regulatory Affairs professional to provide day to day regulatory support to the clinical project management team.

Key responsibilities:

* Manage all clinical trial applications

* Support IND activities, not just the final dossier, but compiling and building it up in the correct format for the relevant regulatory body (FDA/MHRA)

* Write and submit orphan drug applications, this is essential

* Write and review all regulatory documents

* Support NDA/MAA planning

This role will require attention to detail and knowledge in the end to end regulatory process from pre-clinical and orphan drug applications, right through to taking the final product to market.

This person will need to be hand in hand with the relevant internal departments and the external regulatory bodies to ensure complete management of all stages. They will also need the insight to challenge when required and give guidance and accurate regulatory advice as needed.

If you feel you have the necessary insight and experience in pharmaceutical regulatory affairs, then please apply and attach your up to date CV for consideration
Role: Regulatory Affairs Manager
Job Type: Permanent
Location: Edinburgh, City of Edinburgh,

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