Related skills
clinical trials regulatory submissions tmf irb/ec site activation📋 Description
- Deliver site activation readiness on time for assigned country/sites, mitigating risks.
- Prepare Clinical Trial Applications and submission dossiers per local rules.
- Interact with CA/EC for study purposes; respond to CA/EC inquiries.
- Provide regular updates to Start Up Lead, Regulatory Lead, and Project Manager.
- Maintain project plans, trackers, and regulatory tools for the study.
- Develop start-up plans, IMP release requirements, and document review criteria.
🎯 Requirements
- Bachelor’s degree in life sciences or RN; equivalent experience.
- Pharmacy qualification would be beneficial.
- Demonstrated Regulatory or Start Up experience in CRO/pharma.
- Strong communication and organizational skills.
- Experience with computerized information systems, spreadsheets and email.
- Fluency in English.
- Preferred: site start-up/regulatory experience (feasibility, contracts, CA/EC/IRB).
- Advanced degree (MD/PhD/PharmD) or RAC/Masters in Regulatory Science.
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Operations Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!