Specialist/Snr Specialist Study Start Up and Regulatory Affairs

📋 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

🎯 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

🎁 Benefits

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