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Senior Regulatory Affairs Manager (RARE DISEASES)

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Hays

2021-12-03 10:06:40

Job location London City, Greater London, United Kingdom

Job type: fulltime

Job industry: Government & Defence

Job description

REGULATORY AFFAIRS \/ ORPHAN DRUG \/ RARE DISEASES \/ FULL LIFECYCLE \/ CTA \/ ODD\/ PIPS \/ 12M CONTRACT

Your new company
An American pharmaceutical company are looking for a Regulatory Senior Manager to join their UK based team. They have an exciting portfolio and a drive to help cure those with rare diseases.

Your new role
You will be coming in as a regulatory affairs senior manager for the UK team, working on full lifecycle of the products. You will have experience with CTAs, MAAs, and some post approval work. This is a strategic position and will require experience with scientific advice, PIPS, and of course, Orphan drug experience. You will be responsible for the EU portfolio along with your team, working on developing this exciting portfolio. As this is an American company, you will also be conversing with the US team regularly.

What you'll need to succeed
You will need to have at least 5-6 years' regulatory affairs experience working with EU products. You will have experience working on regulatory affairs for orphan drugs, pips, and have some experience with scientific advice. This is a London based company and so you must be located in the UK.

What you'll get in return
This is an initial 12 month contract and has the scope to be extended. There is a large increase in workload and they need someone with both a strategic and operational experience in regulatory affairs.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV. Please reach out via LinkedIn to Julia Bowden, Senior Recruitment Consultant at Hays Life Sciences if you would like to discuss further.

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