Responsibilities
- Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments in Europe (EU, UK (post-Brexit) and Switzerland). Support for rest-of-the-world clinical trial applications may be required
- Contribute to the regulatory strategy by bringing the European insights into discussions
- Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the agreed regulatory strategy for development medicinal products
- Work with regulatory affairs consultants/service providers on CTA submissions
Requirements
- Minimum of 4 years of experience managing regulatory submissions, with a primary focus on clinical trial applications and associated tasks
- BSc; MSc or PhD in a life sciences discipline
- Fluent in English (written and spoken)
- Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union
- Knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)
This position can be performed 100% remote.
