Specialist/Snr Specialist Study Start Up and Regulatory Affairs

📋 Description

• Lead and coordinate activities to achieve site initiation readiness.
• Provide subject matter expertise and ensure regulatory compliance.
• Act as liaison between internal teams, clients and external stakeholders.
• Deliver study start-up and regulatory milestones within defined scope.
• Decide on regulatory processes and documentation approaches within scope.
• Manage medium-complexity regulatory environments and multi-country requirements.

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent.
• Minimum 4 years in pharma/CRO or regulatory body.
• Strong knowledge of ICH-GCP and national regulations for territories of competency.
• Understanding of country requirements for SSU/Regulatory in multiple European/Americas regions.

🎁 Benefits

• Collaborative, international team with global opportunities.
• Flexible work arrangements and emphasis on work-life balance.
• Culture focused on quality, integrity and agility.