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Regulatory Affairs CMC Manager

US TECH SOLUTIONS LIMITED
Job LocationCambridge
EducationNot Mentioned
Salary£448.00 - £458.00 per day
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time

Job Description

An Exciting Role to work for one of the Global biopharmaceutical company.Title: Regulatory Affairs CMC managerDuration: 12 month contract RoleLocation: Cambridge - (Hybrid Role)Knowledge, Experience and Skills:

  • Must have significant experience in regulatory affairs and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements
  • Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
  • Well versed and competent with regulatory documentation and submission management systems
  • Excellent verbal, written and interpersonal communication skills are required
  • Must have excellent organizational skills and an ability to work on a number of projects with tight timelines.

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