Regulatory Affairs Manager EU

Regulatory Affairs Manager, EU, Oncology, contractor
Regulatory Affairs Manager EU Oncology

Your new company
This global biopharmaceutical company is looking for an experienced Regulatory Affairs Manager to join their EU Oncology Regulatory team based in Uxbridge, this is a 12 month contract with scope for extension

Your new role
In this contract job the Regulatory Affairs Manager will be responsible for supporting one or more products development and/or marketed products from an EU regulatory perspective.

The Regulatory Affairs Manager is responsible for advising the GRT on regional considerations in developing strategy and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders You will provide content guidance for regional regulatory documents and meetings in accordance with strategy and provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan)

What you'll need to succeed
In order to be considered for this 12 month contract job as Regulatory Affairs Manager you must have previous experience working in a similar role and oncology experience would be advantageous An awareness of the regulatory procedures in EU for MAs, CTAs, post approval changes and amendments, extensions and renewals is essential along with knowledge of drug development

What you need to do now
For more information on this or any other Regulatory Affairs contract jobs please apply to this advert and ask for Victoria Dunlop

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Job type:
Working Pattern
Regulatory Affairs
£48 - £58 per hour umbrella
Apply Now

Talk to a consultant

Talk to Victoria Dunlop, the specialist consultant managing this position, located in London-City

4th Floor, 107 Cheapside

Telephone: 0203 4650064

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