Specialist/Snr Specialist Study Start Up and Regulatory Affairs

📋 Description

• Lead and coordinate start-up/regulatory activities to achieve site initiation readiness
• Act as SME; ensure regulatory compliance and liaise with teams, clients, stakeholders
• Deliver assigned study start-up and regulatory milestones within scope
• Make independent regulatory process decisions within scope
• Manage multi-country regulatory environments where applicable
• Prepare, review, and QC regulatory/study-start-up docs (submissions, essential docs, translations)

🎯 Requirements

• Graduate degree in Chemistry/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 for Europe/ Americas

🎁 Benefits

• Join a collaborative, international team with focus on rare disease and oncology
• Culture emphasizing quality, integrity, drive, agility, and belonging
• Opportunity to contribute to patients' access to therapies and impactful trials