Specialist/Snr Specialist Study Start Up and Regulatory Affairs

Added
1 day ago
Type
Full time
Salary
Salary not provided

Related skills

documentation regulatory affairs ich-gcp regulatory strategy translations

๐Ÿ“‹ Description

  • Lead and coordinate study start-up and regulatory activities
  • Ensure regulatory compliance across multiple countries
  • Act as liaison between internal teams, clients and stakeholders
  • Deliver study start-up milestones within defined scope and timelines
  • Prepare, review and QC regulatory docs and translations
  • Develop SSU strategy, SOPs and core documents

๐ŸŽฏ Requirements

  • Graduate degree in Chemistry/Life Sciences or Nursing
  • Min 4 years pharma/CRO or regulatory experience
  • Knowledge of ICH GCP and national regs
  • Understanding multi-country SSU/regulatory delivery in Europe/Americas

๐ŸŽ Benefits

  • Collaborative international team
  • Flexible, patient-focused culture
  • Opportunities to impact early-phase trials
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