Related skills
regulatory affairs clinical trials start-up tmf ich-gcp📋 Description
- Ensure timely site activation readiness for assigned country/sites.
- Coordinate country-level submissions and site activation with RSSs.
- Prepare CTAs and submission dossiers for CA/EC per local rules.
- Maintain project plans, trackers, and regulatory intelligence; update Leads.
- Collaborate with site CRA to align communication and site activation.
- Maintain TMF readiness and document control; support pre-study visits when needed.
🎯 Requirements
- Bachelor's degree in life sciences or RN or equivalent.
- 5+ years as Regulatory or Start-Up specialist in CRO/pharma.
- Excellent communication and organizational skills.
- Experience with regulatory information systems, TMF, MS Office.
- Fluency in English and Turkish.
- Preferred: country start-up/regulatory exp; milestone tracking; RAC/advanced degree.
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