Senior Regulatory Start-Up Specialist (Remote)

Precision Medicine Group, LLC.; Turkey; On-site; TRY 400,000 - 700,000; Full time

Job summary

Precision for Medicine seeks a Principal Regulatory and Start Up Specialist to lead regulatory start-up activities in Turkey, ensuring timely site activations. You will coordinate country submissions, maintain regulatory trackers, and prepare essential documents for CA/EC approvals.

Required are a life sciences degree (or RN) with 5+ years in regulatory start-up, fluent English and Turkish, and strong coordination with cross functional teams. Remote work within Turkey is supported.

Qualifications

• Bachelor's degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent.
• 5+ years as a Regulatory or Start-Up specialist in CRO or pharmaceutical/biotech industry.
• Fluency in English and Turkish.

Responsibilities

• Deliver site activation readiness within the assigned country/sites on time and with quality.
• Drive country level submissions and site activation by coordinating activities across RSSs.
• Prepare CTAs and submission dossiers for CA, EC and local bodies per requirements.

Skills

Regulatory submissions

Site start-up

Cross-functional coordination

English Turkish fluency

Education

Bachelor's degree in life sciences or healthcare

Advanced degree in medical or life sciences (MD/PhD/PharmD)

Tools

Milestone tracking tools

Job description

Precision for Medicine seeks a Principal Regulatory and Start Up Specialist to lead regulatory start-up activities in Turkey, ensuring timely site activations. You will coordinate country submissions, maintain regulatory trackers, and prepare essential documents for CA/EC approvals.

Required are a life sciences degree (or RN) with 5+ years in regulatory start-up, fluent English and Turkish, and strong coordination with cross functional teams. Remote work within Turkey is supported.