Related skills
regulatory affairs tmf ich-gcp site start-up irb/ec📋 Description
- Deliver timely, quality site activation readiness for assigned sites.
- Prepare CTA forms and submission dossiers for authorities.
- Interact with CA/EC for study submissions and responses.
- Provide updates to Start Up Lead, Regulatory Lead, and PM.
- Maintain project plans, trackers, and regulatory tools.
- Coordinate translations and country/site specific documents.
🎯 Requirements
- Bachelor’s degree in life sciences or RN or equivalent.
- 1+ year as Regulatory or Site Start-Up specialist.
- CRO or pharma start-up regulatory experience.
- Fluency in English; strong communication skills.
- Knowledge of local trial laws and ICH-GCP.
- Experience with milestone tracking tools.
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