Specialist/Snr Specialist Study Start Up and Regulatory Affairs

📋 Description

• Lead and coordinate activities to achieve site initiation readiness.
• Provide regulatory subject matter expertise; ensure compliance and liaison with internal/external
• Deliver study start-up and regulatory milestones within defined scope.
• Make independent regulatory process decisions and manage documentation approaches.
• Handle medium-complexity regulatory environments; multi-country requirements where applicable.
• Lead preparation, review and QC of regulatory/study start-up documents (submissions, essential

🎯 Requirements

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

🎁 Benefits

• Collaborative, international team with opportunities across North America, South America, Europe
• Culture emphasizing quality, integrity, drive, agility, and belonging.
• Opportunity to contribute to challenging, impactful trials in rare diseases and oncology.