Related skills
regulatory affairs clinical trials translation tmf ich-gcp📋 Description
- Ensure site activation readiness and mitigate risks in assigned sites.
- Prepare Clinical Trial Applications and submissions for approvals.
- Interact with CA/EC for study submissions and responses.
- Maintain regulatory plans, trackers and essential TMF documents.
- Customize country/site patient information sheets and ICF.
- Coordinate translations of documents and liaise with site CRA.
🎯 Requirements
- Bachelor's degree in life sciences or RN, or equivalent.
- Pharmacy qualification or Pharmacist experience beneficial.
- 1+ year as Regulatory or Start-Up specialist in CRO/pharma.
- Strong communication and organizational skills.
- Experience with milestone tracking tools and regulatory submissions.
- English language fluency required.
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