Specialist/Snr Specialist Study Start Up and Regulatory Affairs

📋 Description

• Lead and coordinate study start-up and regulatory activities
• Ensure regulatory compliance and timely delivery milestones
• Serve as liaison between internal teams, clients and external stakeholders
• Handle multi-country regulatory environments where applicable
• Prepare, review and QC regulatory documentation and translations
• Develop SSU regulatory strategy and plans

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent
• Minimum 4 years in pharma/CRO or regulatory bodies
• Strong knowledge of ICH-GCP and national regulations
• Understanding of SSU/regulatory delivery across Europe and/or Americas

🎁 Benefits

• Join a collaborative, international team
• Focus on rare disease and oncology trials
• Culture emphasizes quality, integrity and agility
• Supportive environment with work-life balance