Regulatory and Site Start Up Specialist

Added
1 day ago
Location
Type
Full time
Salary
Salary not provided

Related skills

regulatory affairs clinical trials ich-gcp irb ec

📋 Description

  • Lead/regulatory start-up activities for sites/countries.
  • Deliver timely site activation and action plans.
  • Prepare Clinical Trial Applications and submission dossiers.
  • Interact with CA/EC and manage regulatory responses.
  • Maintain TMF and regulatory trackers; ensure compliance.
  • Collaborate with site CRA and project teams.

🎯 Requirements

  • Bachelor's degree in life sciences or RN, or equivalent.
  • 1+ year Regulatory or Site Start-Up experience in CRO/pharma.
  • Strong communication and organizational skills.
  • English fluency; local language for non-English country.
  • Preferred regulatory and site start-up experience for the country.
  • Experience with milestone tracking tools and prioritizing deadlines.
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