Country Start-Up & Regulatory Lead

Precision Medicine Group

Çankaya

On-site

TRY 550,000 - 850,000

Full time

3 days ago

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Job summary

Precision Medicine Group seeks a Principal Regulatory and Start Up Specialist to lead country-level submissions and site activation across our Turkish operations. You will coordinate with RSSs, prepare submission dossiers for CA/EC and local bodies, and ensure alignment with study timelines and regulatory requirements.

You will maintain TMF readiness and drive cross-functional collaborations to enable timely trial start-up.

Qualifications

Bachelor's degree or RN or equivalent combination of education, training and experience.
5+ years as Regulatory or SU specialist in CRO/pharma/biotech preferred.

Responsibilities

Drive country level submissions and site activation with multiple RSSs.
Prepare Clinical Trial Application forms and submission dossiers for CA, EC, and local bodies.
Interact with CA/EC and provide responses; update Start Up Lead and Project Team.
Maintain project plans, trackers and regulatory intelligence for assigned responsibilities.
Develop country start-up plans, IMP release requirements and essential document review criteria.
Coordinate with site CRA for alignment and secure site collaboration.
Prepare and manage collection of essential documents for site activation/IMP release.
Customize patient information sheets and informed consent forms for the country/site.
Translate/substantiate translations for submission documents; ensure TMF readiness.