Specialist/Snr Specialist Study Start Up and Regulatory Affairs

📋 Description

• Lead and coordinate activities for site initiation readiness
• Provide regulatory subject matter expertise and liaison with teams/clients
• Deliver study start-up and regulatory milestones within scope
• Make independent regulatory process decisions
• Handle medium-complexity regulatory environments multi-country
• Lead start-up docs, submissions, translations for accuracy/compliance

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences or Nursing
• Minimum 4 years in pharma, CRO, or regulatory body
• Good knowledge of ICH GCP and national regs
• Understanding country SSU/regulatory requirements

🎁 Benefits

• Quality-focused culture with integrity and trust
• Agility and responsiveness to timelines
• Collaborative, international team environment
• Commitment to work-life balance