Related skills
regulatory affairs clinical trials ich-gcp irb ec📋 Description
- Lead/regulatory start-up activities for sites/countries.
- Deliver timely site activation and action plans.
- Prepare Clinical Trial Applications and submission dossiers.
- Interact with CA/EC and manage regulatory responses.
- Maintain TMF and regulatory trackers; ensure compliance.
- Collaborate with site CRA and project teams.
🎯 Requirements
- Bachelor's degree in life sciences or RN, or equivalent.
- 1+ year Regulatory or Site Start-Up experience in CRO/pharma.
- Strong communication and organizational skills.
- English fluency; local language for non-English country.
- Preferred regulatory and site start-up experience for the country.
- Experience with milestone tracking tools and prioritizing deadlines.
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