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 assigned study start-up and regulatory milestones within scope.
• Make independent decisions on regulatory processes and documentation approaches.
• Handle medium-complexity regulatory environments, including multi-country requirements.

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent.
• Minimum 4 years in pharma/CRO or regulatory body.
• Good knowledge of ICH GCP and national regulations for territories of competency.
• Understanding of country-specific SSU/Regulatory delivery in Europe and/or the Americas.

🎁 Benefits

• Company information and values focused on collaboration and work-life balance.