Related skills
ms office gcp project management regulatory affairs clinical trials📋 Description
- Provides regulatory guidance through the clinical development life cycle
- Compile and review submissions to Regulatory Authorities (CTA/IND, annual reports)
- Develops and reviews documents for submissions to authorities
- Represent Global Regulatory Affairs at project team meetings
- Lead projects for the region or global regulatory submissions
- Maintain project plans, trackers and regulatory intelligence tools
🎯 Requirements
- Bachelors degree or equivalent in science/healthcare
- 5 years regulatory experience for Manager or 7 years for Senior Manager
- Proficient with MS Office / Office 365
- Fluent in English
- Regulatory affairs experience with CRO; lead submissions
- Knowledge of EU/US regulatory processes; ICH GCP
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