Regulatory and Start Up Specialist / Senior Regulatory and Start Up Specialist

📋 Description

• Deliver site activation readiness for assigned country/sites.
• Coordinate country-level submissions when multiple RSSs are assigned.
• Prepare CTAs and submission dossiers for local bodies.
• Interact with CA/EC for study purposes and responses.
• Maintain regulatory plans, trackers, and TMF readiness.
• Support start-up plans and essential document reviews.

🎯 Requirements

• Bachelor's degree in life sciences or RN or equivalent.
• 5+ years as Regulatory or Start-up specialist in CRO/pharma.
• Fluency in English and Turkish.
• Excellent communication and organizational skills.
• Experience with regulatory systems, CA/EC submissions, and ICH-GCP.

🎁 Benefits

• Remote work opportunity with a global team.
• Impact on cancer therapies research for patients.
• Inclusive, collaborative culture with input valued.
• Equal Opportunity Employer.
• Occasional travel may be required.