Specialist/Snr Specialist Study Start Up and Regulatory Affairs

📋 Description

• Lead and coordinate study start up and regulatory activities
• Ensure regulatory compliance and liaise with internal/external stakeholders
• Deliver assigned start-up and regulatory milestones within scope
• Make independent regulatory process decisions
• Handle medium complexity regulatory environments
• Lead SSU activities for countries/projects with timelines and quality goals

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent
• Minimum 4 years in pharma/CRO or regulatory body
• Solid knowledge of ICH GCP and national regs
• Understanding of country-specific SSU/regulatory delivery in Europe/Americas

🎁 Benefits

• Quality is a core value
• Integrity and trust in actions
• Drive and passion for outcomes
• Agility and responsiveness to patients
• Belonging and inclusivity
• Collaborative partnerships and teamwork