Related skills
regulatory affairs start-up ich-gcp irb clinical trial application📋 Description
- Deliver site activation readiness for assigned country/sites on time.
- Prepare Clinical Trial Applications and submission dossiers.
- Interact with CA/EC; handle responses.
- Maintain project plans, trackers, and regulatory tools.
- Coordinate translations for regulatory documents.
- Review and collect documents for site activation/IMP release.
🎯 Requirements
- Bachelor’s degree in life sciences or RN; pharmacy background helpful.
- Demonstrated contracts and budgeting negotiation experience.
- Regulatory or Start-Up experience in CRO/pharma preferred.
- Strong communication and organizational skills.
- Proficiency with MS Office and electronic systems.
- Fluency in English; RAC/advanced degree preferred.
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