Related skills
regulatory submissions tmf translations site activation clinical trial applications📋 Description
- Deliver site activation readiness on time and to quality standards.
- Prepare Clinical Trial Applications and dossiers per local requirements.
- Interact with CA/EC and respond to CA/EC questions.
- Maintain project plans, trackers, and regulatory tools.
- Develop start-up plans and essential document review criteria.
- Coordinate with site CRAs to ensure alignment on activation.
🎯 Requirements
- Bachelor’s degree in life sciences or RN, or equivalent.
- Pharmacy background is beneficial.
- 1+ year as Regulatory or Start-Up specialist in CRO/pharma.
- Fluency in English; strong communication and organizational skills.
- Experience with CA/EC submissions, feasibility, and budgets.
- Advanced degree or RAC certification preferred.
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