(Senior) Start Up & Regulatory Specialist

📋 Description

• Lead site activation readiness within assigned country/sites, ensuring timely and quality
• Coordinate country-level submissions and site activation with multiple RSSs in the country.
• Prepare Clinical Trial Applications and submission dossiers for CA/EC and local bodies per
• Engage with authorities (CA/EC) for study purposes and manage responses.
• Maintain project plans, trackers and regulatory intelligence for the study.
• Support study start-up plans, IMP release requirements and essential document reviews.

🎯 Requirements

• Bachelors in life sciences or RN or equivalent; 5+ years as Regulatory or Start-Up specialist in
• Excellent communication and organizational skills; proficient with electronic systems and MS Office.
• Fluency in English and Turkish; ability to prioritize workload and meet deadlines.
• Experience in cross-functional coordination, budget negotiations and site activation processes.
• Knowledge of GCP/ICH guidelines and regulatory requirements; strong documentation discipline.

🎁 Benefits

• Remote-friendly role with international exposure.
• Opportunity to influence start-up strategies and regulatory processes.
• Supportive team environment and potential for growth within Precision Medicine Group.