Added
1 day ago
Type
Full time
Salary
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Related skills

regulatory affairs regulatory submissions clinical development ich-gcp eu regulatory

πŸ“‹ Description

  • Provides regulatory guidance across the clinical development lifecycle
  • Coordinates and reviews submissions to Regulatory Authorities and Ethics Committees
  • Represents Global Regulatory Affairs at project team meetings
  • Maintains regulatory plans and intelligence tools; updates leadership

🎯 Requirements

  • Bachelor's degree or equivalent in science/healthcare
  • 5+ years of regulatory affairs experience
  • Strong knowledge of EU and US regulatory processes
  • Experience with regulatory submissions (CTA/IND), and meetings
  • ICH-GCP guidance and high-quality documentation practices
  • Excellent written and verbal English; MS Office proficiency

🎁 Benefits

  • Discretionary annual bonus
  • Health insurance
  • Retirement savings benefits
  • Life insurance
  • Parental leave
  • Paid time off
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