Global Regulatory Start-Up Leader

Precision For Medicine; Çankaya; On-site; TRY 900,000 - 1,300,000; Full time

Job summary

Precision for Medicine seeks a Principal Regulatory and Start Up Specialist to lead country-level submissions and site activation. You will coordinate regulatory activities with CA/EC, prepare dossiers, and ensure timely approvals in line with ICH-GCP and local regulations.

The role requires collaboration with Regulatory, Start-Up, and Clinical Operations teams across countries. The candidate should have a life sciences background with 5+ years in regulatory/start-up roles, fluency in English

Qualifications

• Bachelor's degree or RN with 5+ years regulatory/start-up experience
• Fluency in English and Turkish
• Experience driving cross-functional activities
• Knowledge of GCP/ICH guidelines and regulatory requirements

Responsibilities

• Drive country-level submissions and site activation within the country
• Prepare and manage Clinical Trial Application forms and submission dossiers
• Interact with CA/EC and respond to requests
• Maintain project plans, trackers, and regulatory intelligence tools
• Coordinate translations and essential document collection for site activation/IMP release
• Mentor staff on country regulations and internal procedures

Skills

Regulatory submissions coordination

Site activation coordination

Cross-functional collaboration

Regulatory intelligence

Education

Bachelor's degree in life sciences or related field

Registered Nurse (RN) or equivalent

Tools

Milestone tracking tools

TMF/eTMF systems

Job description

Precision for Medicine seeks a Principal Regulatory and Start Up Specialist to lead country-level submissions and site activation. You will coordinate regulatory activities with CA/EC, prepare dossiers, and ensure timely approvals in line with ICH-GCP and local regulations.

The role requires collaboration with Regulatory, Start-Up, and Clinical Operations teams across countries. The candidate should have a life sciences background with 5+ years in regulatory/start-up roles, fluency in English