Study Start Up and Regulatory Affairs Specialist

📋 Description

• Lead study start-up and regulatory activities for assigned countries/projects
• Prepare, review, and QC regulatory and study start-up documentation
• Draft, negotiate, and execute clinical site and ancillary agreements
• Review labels, patient info sheets, diary cards for ICH-GCP compliance
• Provide regulatory/SSU strategic input and develop regulatory strategy
• Escalate risks and support corrective/preventive actions

🎯 Requirements

• Graduate degree in Chemistry, Life Sciences, or Nursing
• Experience in pharmaceutical or CRO industry or regulatory body
• Good knowledge of ICH GCP and national regulations
• Understanding of SSU/Regulatory requirements in Europe/Americas

🎁 Benefits

• Collaborative international team
• Flexibility and work-life balance
• Purpose-driven work in clinical research
• Career growth and ownership opportunities