Related skills
regulatory affairs eu regulations clinical trials regulatory submissions cro📋 Description
- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review CTA/IND submissions and related regulatory documents
- Develops and/or reviews documents for regulatory submissions to ensure compliance
- Represents Global Regulatory Affairs at project team meetings with internal and external clients
- Leads the project for the region or globally and coordinates RA specialists
- Maintains project plans, trackers and regulatory intelligence tools
🎯 Requirements
- Bachelor's degree or equivalent; science/healthcare preferred
- 5+ years regulatory experience for Manager; 7+ years for Senior Manager
- CRO background with leading clinical submissions
- Knowledge of EU/US regulatory requirements (IND/CTA)
- MS Office proficiency; fluent in English
- Willingness to travel domestically and internationally
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