Related skills
regulatory affairs clinical trials regulatory submissions regulatory strategy cta/ind📋 Description
- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review regulatory submissions (CTA/IND, annual reports, orphan designations, paediatric planning)
- Develops and/or reviews documents for submission to Regulators and Ethics Committees
- Represents Global Regulatory Affairs at project team meetings
- Leads projects for the region or globally when needed
- Oversees and coordinates Regulatory Affairs Specialists to meet submission targets
🎯 Requirements
- Bachelor's degree (or equivalent) in a scientific or healthcare field
- 5 years regulatory experience for Manager; 7 years for Senior Manager
- Computer literacy (MS Office / Office 365)
- Fluent in English
- Regulatory affairs experience with a CRO and leading clinical submissions
- Knowledge of EU/US drug development and INDs/CTAs
🎁 Benefits
- Discretionary annual bonus
- Private medical insurance
- MultiSport Card
- Life insurance
- Pension
- Home working allowance
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