Related skills
regulatory affairs clinical trials regulatory submissions ich-gcp cta/ind📋 Description
- Provides regulatory guidance throughout the clinical development life cycle
- Compiles, coordinates and reviews regulatory submissions (CTA/IND, reports)
- Develops and/or reviews documents for submission to regulatory authorities and ethics committees
- Represents Global Regulatory Affairs at project team meetings
- Leads project for the region or globally and coordinates RA specialists
- Maintains project plans, trackers and regulatory intelligence tools
🎯 Requirements
- Bachelor's degree or equivalent in a scientific or healthcare discipline
- 5 years regulatory experience for Manager; 7 years for Senior Manager
- Computer literacy (MS Office/Office 365)
- Fluent in English
- Graduate/postgraduate preferred
- Basic understanding of financial management
🎁 Benefits
- Discretionary annual bonus
- Private medical insurance
- MultiSport Card
- Life insurance
- Pension
- Home working allowance
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