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Senior Manager Regulatory Affairs EU Virology

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Hays

2021-12-03 15:03:59

Job location Cambourne, Cambridgeshire, United Kingdom

Job type: fulltime

Job industry: Government & Defence

Job description

Regulatory Affairs Senior Manager | Virology | Established Products

Regulatory Affairs Senior Manager, Regulatory Submissions, Virology, CTAs, Complex Variations, EU, PIPs

Your new company
This Multi-National biopharmaceutical company are looking for someone to join their Virology team as Regulatory Affairs Senior Manager. Being a part of the Regulatory Affairs Virology team gives you the opportunity to work across an innovative and fast-paced portfolio, across life-threatening diseases. This will be based in the company's Uxbridge or Cambridge site.

Your new role
By joining the Virology team as Regulatory Affairs Senior Manager, you will get the opportunity to work on life-threatening diseases such as HIV, Hepatitis, and Emerging Viruses. This is a senior leadership position, where submissions will be targeted across Centralized European markets as well as Canadian, Australian and Brexit-related activities. You will mainly be expected to work on post-approval maintenance related activities, such as renewals, variations and site transfers for one of their established products. There will also be some support on early development and clinical trial submissions and strategies. Additionally, some operational regulatory activities will be expected as well.

Main Responsibilities

* Post-Marketing Submissions across: Complex Variations, PIPs, Line Extensions, Renewals Technical for established product
* Regulatory Affairs strategy development
* Initial Submissions across: CTAs, MAAs, PIPs, Labelling
* Independent product ownership
* Strong Labelling knowledge
* Communication with cross-functionally
* European (CP) market submissions (Essential)
* Canada, Australia, Brexit market submissions (Desirable)

What you'll get in return
You will get the opportunity to work with a top 10 pharma across an extremely innovative product portfolio. You will be compensated generously for the high level of responsibility of the role and have ample opportunity for progression internally. You must have right to work in the UK

What you need to do now
Please click \"apply now\" to forward an updated version of your CV.

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