Related skills
regulatory affairs tmf ich-gcp site activation clinical trial applications📋 Description
- Deliver site activation readiness for assigned country/sites; mitigate risks.
- Prepare Clinical Trial Applications and submission dossiers to authorities per local requirements on time.
- Interact with CA/EC and respond to queries.
- Provide regular updates to Start Up Lead, Regulatory Lead, and Project Team.
- Maintain project plans, trackers, and regulatory tools.
- Support start-up plans, IMP release needs, and document review.
🎯 Requirements
- Bachelor's degree in life sciences or RN, or equivalent.
- Pharmacy qualification or pharmacist experience beneficial.
- 1+ year in regulatory or start-up roles in CRO or pharma.
- Strong communication and organizational skills.
- Experience with computerized systems, spreadsheets, word processing, and email.
- Fluency in English.
🎁 Benefits
- Equal Opportunity Employer.
- Collaborative, value-driven culture.
- Impactful work in cancer therapies.
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