Specialist/Snr Specialist Study Start Up and Regulatory Affairs

📋 Description

• The Senior Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities
• Provides subject matter expertise, ensures regulatory compliance, and serves as a key liaison with
• Accountable for delivery of assigned study start-up and regulatory milestones within defined scope.
• Make independent decisions regarding regulatory processes and documentation approaches.
• Handles medium-complexity regulatory environments, including multi-country requirements where
• Leads study start-up and regulatory activities for assigned countries or projects, ensuring timely

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and
• Minimum 4 years within pharmaceutical or CRO industry or regulatory body
• Good knowledge of ICH GCP and national regulations for territories of competency
• Good understanding of country requirements pertaining to SSU/Regulatory delivery in multiple

🎁 Benefits

• We look forward to welcoming your application and offer a collaborative, international team