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Regulatory Affairs Manager UK/I Affiliate

Job LocationLondon
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time

Job Description

AFFILIATE REGULATORY AFFAIRS MANAGER | UK&I | VIROLOGY An leading biopharmaceutical company within the are looking to bring in a Regulatory Affairs Manager into the team on a 12 month contract. A well-known and exciting bio-pharmaceutical company focusing on the research, development, and commercialization of life-threateningdiseases around the world.Your new roleAs the Affiliate Senior Regulatory Affairs Manager/ Regulatory Affairs Manager you will:

  • You will report into the head of UK&I and support local execution of the EU Regional strategy, which includes full lifecycle submissions, with a focus in antiviral products.
  • You will assist in the coordination and execution of regulatory submissions for the UK and Ireland
  • Managing the initial MAA applications, variations, and maintenance applications
  • Filing of CTAS, any amendments and other clinical trial submissions
  • Assisting with the local coordination and execution of the regulatory submissions.
What youll need to succeed
  • Minimum 5-8 years Regulatory Affairs Experience, with 5 years experience in UK&I Affiliate Regulatory role
  • Science degree/ masters
  • Knowledge of UK&I regulatory guidelines and legislation
  • Highly experienced in filling national variations to the MHRA
  • Experience reviewing promotional & non-promotional material for UK&I
  • Full-lifecycle experience in regulatory affairs
  • Strong Communication and teamwork
  • Virology experience (desired)
What youll get in returnThis is a 12 month contract within IR35. Hybrid working, 2 days on site per week in London. What you need to do nowIf youre interested in this role, click apply now to forward an up-to-date copy of your CV, or call us now.If this job isnt quite right for you but you are looking for a new position, please contact Julia Bowden for a confidential discussion on your career.

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