Related skills
regulatory affairs tmf ich-gcp site start-up irb/ec📋 Description
- Deliver timely site activation readiness for assigned country/sites and mitigate risks.
- Prepare Clinical Trial Applications and submission dossiers on time.
- Liaise with CA/EC for study submissions and responses.
- Update Start Up Lead, Regulatory Lead, and Project Manager on submissions.
- Maintain project plans, trackers, and regulatory tools for assigned duties.
- Customize country/site specific Patient Information Sheet and ICF.
🎯 Requirements
- Bachelor’s degree in life sciences or RN or equivalent.
- Pharmacy/Pharmacist background would be highly beneficial.
- 1+ year regulatory or site-start-up experience in CRO/pharma.
- Strong communication and organizational skills.
- Experience with computerized systems, spreadsheets, word processing, and email.
- Fluency in English.
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!