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Senior Manager Regulatory Affairs EU Virology

Job LocationCambridge
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent,full-timeB

Job Description

Regulatory Affairs Senior Manager | Virology | Established ProductsRegulatory Affairs Senior Manager, Regulatory Submissions, Virology, CTAs, Complex Variations, EU, PIPsYour new companyThis 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-pacedportfolio, across life-threatening diseases. This will be based in the companys Uxbridge or Cambridge site.Your new roleBy 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 acrossCentralized 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 establishedproducts.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 youll get in returnYou 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 UKWhat you need to do nowPlease click "apply now" to forward an updated version of your CV.

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