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Senior Regulatory Affairs Manager

Job LocationNottingham
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent,full-time

Job Description

Senior Manager - Regulatory Affairs UK Based - Remote (Can be done from anywhere in the UK) Competitive Salary A leading CRO are keen to recruit Senior Regulatory Managers to join their team working remotely across the UK. The Senior Regulatory Managers will join an expanding team, working on UK based phase I clinical trial submissionsThe role will involve authoring, compiling and reviewing regulatory submissions as well as working closely with the regulatory bodies.The role:

  • Act as Regulatory Lead for cross-functional project teams
  • Coordinate and author submissions (CTA, ARSAC, REC) for phase I clinical studies. Responsible for timely delivery on submissions.
  • Act as the main contact for regulatory bodies - MHRA, REC & ARSAC
  • Review sponsor documentation for submissions
  • Oversee post-submission activities
Requirements:
  • Experience working as a regulatory lead in a CRO or pharmaceutical company
  • Experience of phase I clinical trial submissions
  • Experience liaising with regulatory bodies & sponsors/external partners
  • Strong communication is essential for this role
If youre an experienced Regulatory Manager looking for your next step then please apply online.

Keyskills :
Clinical TrialsRegulatory AffairsRegulatory RequirementsPhase OneRegulatory Submissions

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