Senior Regulatory Affairs Manager EU

Senior Regulatory Affairs Manager, Oncology, PIP, ODD, contract job
Senior Regulatory Affairs Manager EU contract job

Your new company
This global biotech are looking for an experienced Senior Regulatory Affairs Manager to join their established teams in either Cambridge or Uxbridge

Your new role
As Senior Regulatory Affairs Manager within the oncology group you will be responsible for planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products within assigned portfolio in compliance with global filing plans and local regulatory requirements.

The Senior Regulatory Affairs Manager is responsible for implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements and leading the development of regional regulatory documents and meetings in accordance with GRT strategy

The Senior Regulatory Affairs Manager will play a key role in regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)

What you need to do now
This is a contract job initially for 12 months with scope for extension. For more information on this or any other contract jobs in Regulatory Affairs please apply to this advert and ask for Victoria Dunlop
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Job type:
Working Pattern
Regulatory Affairs
£52 - £62 Umbrella rate
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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