Lead Start-Up & Regulatory Specialist

Precisionmedicinegroup; Turkey; Hybrid; TRY 450,000 - 750,000; Full time

Job summary

Precision Medicine Group in Turkey seeks a Principal Regulatory and Start Up Specialist to lead country level submissions and activation processes, coordinating across RSSs and site teams to ensure on-time approvals.

You will prepare Clinical Trial Applications and submission dossiers for CA/EC, manage timelines, maintain regulatory trackers, and mentor junior staff while partnering with CRA and other functions.

Qualifications

• Bachelor's degree in life sciences or related field or RN or equivalent
• 5+ years as Regulatory or Start Up specialist in CRO/pharma
• Fluency in English and Turkish
• Excellent communication and organizational skills

Responsibilities

• Drive country level submissions and site activation in Turkey.
• Prepare Clinical Trial Applications and submission dossiers for local authorities.
• Coordinate with CA/EC and regulatory agencies; manage timelines.
• Maintain TMF and regulatory trackers; support start-up plans.
• Mentor junior staff and coordinate with cross-functional teams.

Skills

Regulatory submissions

Cross-functional coordination

Project management

English and Turkish fluency

Education

Bachelor's degree in life sciences or related field

Registered Nurse (RN) or equivalent

Tools

Milestone tracking tools

Electronic spreadsheets (Excel)

Job description

Precision Medicine Group in Turkey seeks a Principal Regulatory and Start Up Specialist to lead country level submissions and activation processes, coordinating across RSSs and site teams to ensure on-time approvals.

You will prepare Clinical Trial Applications and submission dossiers for CA/EC, manage timelines, maintain regulatory trackers, and mentor junior staff while partnering with CRA and other functions.