Remote Regulatory & Start-Up Specialist

Precision Medicine Group; Turkey; On-site; TRY 90,000 - 130,000; Full time

Job summary

Precision Medicine Group is seeking a Regulatory and Start-Up Specialist to join our Türkiye team. The role focuses on site activation readiness, regulatory submissions, and coordination across cross-functional groups to enable timely clinical trials in the country.

The candidate will manage documentation, translations, budgets, and interactions with competent authorities, ethics committees, and site contracts, ensuring compliance with ICH-GCP and local regulations.

Qualifications

• 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.

Responsibilities

• Ensure site activation readiness within assigned country/sites and manage risks.
• Drive country-level submissions and site activation by coordinating multiple RSSs.
• Prepare and submit Clinical Trial Applications and dossiers per local requirements and timelines.

Skills

Communication skills

Organizational skills

Cross-functional coordination

Turkish language

English language

Prioritization

Independence

Travel flexibility

Education

Bachelor's degree in life sciences or RN

Job description

Precision Medicine Group is seeking a Regulatory and Start-Up Specialist to join our Türkiye team. The role focuses on site activation readiness, regulatory submissions, and coordination across cross-functional groups to enable timely clinical trials in the country.

The candidate will manage documentation, translations, budgets, and interactions with competent authorities, ethics committees, and site contracts, ensuring compliance with ICH-GCP and local regulations.