Senior Regulatory & Start-Up Specialist

Pfm; Turkey; On-site; TRY 3,764,000 - 5,695,000; Full time

Job summary

Precision Medicine Group is seeking a Principal Regulatory and Start Up Specialist to drive country-level submissions and site activation activities. You will coordinate regulatory planning, document management, and cross-functional collaboration to ensure on-time site activation for multiple studies.

The role requires strong English and Turkish language skills, extensive regulatory start-up experience in CRO or pharma, and mentoring capabilities to support junior staff.

Qualifications

• Lead country-level regulatory submissions and site activation.
• Coordinate start-up activities across multiple sites and RSSs.
• Maintain knowledge of local clinical trial laws and regulatory requirements.

Responsibilities

• Drive CA/EC submissions and responses.
• Prepare/maintain study start-up plans and essential documents.
• Collaborate with site CRA and other functions for activation readiness.
• Translate and coordinate documents for submission as needed.
• Mentor junior staff on regulatory start-up processes.

Skills

Regulatory submissions

Start-up management

Cross-functional coordination

ICH-GCP knowledge

Education

Bachelor's in life sciences

RN or equivalent

Tools

Milestone tracking tools

Job description

Precision Medicine Group is seeking a Principal Regulatory and Start Up Specialist to drive country-level submissions and site activation activities. You will coordinate regulatory planning, document management, and cross-functional collaboration to ensure on-time site activation for multiple studies.

The role requires strong English and Turkish language skills, extensive regulatory start-up experience in CRO or pharma, and mentoring capabilities to support junior staff.