Senior Start-Up & Regulatory Lead (Remote)

Precision Medicine Group; Turkey; Remote; TRY 180,000 - 300,000; Full time

Job summary

Precision Medicine Group in Turkey seeks a Senior Start Up & Regulatory Specialist to lead country start-up activities, regulatory submissions, and site activation readiness across assigned sites.

Strong knowledge of local laws, ICH-GCP, and experience coordinating cross-functional teams is required. Fluency in English and Turkish is essential.

You will mentor junior staff and manage documents to ensure timely approvals and compliant trial conduct.

Qualifications

• Bachelor's degree in life sciences or RN with healthcare background.
• 5+ years as Regulatory or Start Up specialist in CRO/pharma/biotech environment.

Responsibilities

• Deliver site activation readiness for assigned country/sites on time and with quality.
• Drive country-level submissions and site activation by coordinating activities.
• Prepare Clinical Trial Application Forms and submission dossiers for CA/EC and local bodies.
• Interact with CA/EC and respond to queries.
• Maintain project plans, trackers, and regulatory intelligence tools.

Skills

English fluency

Turkish fluency

Communication skills

Organizational skills

Regulatory/start-up experience

Education

Bachelor's degree in life sciences

Registered Nurse (RN)

Tools

Milestone tracking tools

MS Office / spreadsheet software

Electronic data capture (EDC) systems

Job description

Precision Medicine Group in Turkey seeks a Senior Start Up & Regulatory Specialist to lead country start-up activities, regulatory submissions, and site activation readiness across assigned sites.

Strong knowledge of local laws, ICH-GCP, and experience coordinating cross-functional teams is required. Fluency in English and Turkish is essential.

You will mentor junior staff and manage documents to ensure timely approvals and compliant trial conduct.