Specialist/Snr Specialist Study Start Up and Regulatory Affairs

📋 Description

• Lead and coordinate study start up and regulatory activities to achieve site initiation readiness
• Provide regulatory SME guidance to internal teams, clients, and external stakeholders
• Deliver assigned regulatory milestones within defined scope
• Make independent regulatory process decisions within scope
• Manage medium-complexity regulatory environments and multi-country requirements
• Lead preparation, review, and QC of regulatory and SSU documents (submissions, essential docs

🎯 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-specific SSU/Regulatory delivery in Europe and/or the Americas

🎁 Benefits

• Join a specialist CRO focused on rare diseases and oncology
• International, collaborative team across North America, South America, Europe, Asia, and Australia
• Culture emphasizes quality, integrity, drive, agility, belonging, and collaboration