Study Start Up and Regulatory Affairs Specialist

📋 Description

• Accountable for delivery of assigned study start-up and regulatory milestones within defined scope.
• Make independent decisions within assigned scope regarding regulatory processes and documentation
• Handles medium-complexity regulatory environments, including multi-country requirements where
• Leads study start-up and regulatory activities for assigned countries or projects of medium
• Leads preparation, review, and quality control of regulatory and study start-up documentation
• Responsible for drafting, negotiating, finalizing, and executing clinical site agreements

🎯 Requirements

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