Related skills
regulatory affairs clinical trials tmf ich-gcp irb📋 Description
- Deliver timely site activation readiness for assigned sites.
- Prepare Clinical Trial Applications and submission dossiers per regs.
- Interface with CA/EC for study submissions and responses.
- Provide updates on CA/EC submissions to Start Up Lead and Project Team.
- Maintain project plans, trackers, and regulatory intelligence tools.
- Support start-up plans, IMP release requirements, and essential document review.
🎯 Requirements
- Bachelor's degree in life sciences or RN or equivalent.
- 1+ year regulatory or start-up experience in CRO or pharma.
- Strong communication and organizational skills.
- English fluency and local language for non-English countries.
- Experience with computerized systems, spreadsheets, and email.
- Knowledge of Good Clinical Practice/ICH guidelines.
🎁 Benefits
- Discretionary annual bonus.
- Health insurance.
- Retirement savings benefits.
- Life insurance and disability benefits.
- Parental leave.
- Paid time off for sick leave and vacation.
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