Related skills
budgeting clinical trials start-up regulatory tmf📋 Description
- Ensure timely site activation readiness and mitigate risks.
- Prepare Clinical Trial Applications and submission dossiers for regulators.
- Interact with CA/EC for approvals and responses.
- Update Start Up Lead/Reg Lead/PM on submissions.
- Maintain project plans, trackers, and regulatory tools.
- Review essential docs for site activation and IMP release; coordinate translations.
🎯 Requirements
- Bachelor's degree in life sciences or RN or equivalent.
- 1+ year as Regulatory or Start-Up specialist in CRO/pharma.
- Pharmacist/Pharmacy background is a plus.
- Strong communication and organizational skills.
- Proficiency with computers, spreadsheets, and email; English fluency.
- Preferred: CA/EC/IRB submissions and start-up feasibility experience.
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