Related skills
documentation start-up regulatory submissions tmf ich-gcp📋 Description
- Ensure timely, compliant site activation across assigned country/sites.
- Prepare Clinical Trial Applications and submission dossiers per local requirements for authorities/EC.
- Interact with CA/EC for study submissions and responses.
- Maintain regulatory plans, trackers, and tools; update leads and PM.
- Develop start-up plans, IMP release needs, and essential document review.
- Collaborate with site CRA to align communication and activation.
🎯 Requirements
- Bachelor's degree in life sciences or RN, or equivalent.
- Pharmacy qualification or pharmacist experience beneficial.
- Regulatory or Start-Up experience in CRO or pharma.
- Strong communication and organizational skills.
- Experience with computerized systems, spreadsheets, word processing, and email.
- Fluency in English.
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