One of our Pharma clients in Switzerland is currently looking for support as:
European Regulatory Affairs - CTA Manager (M/W/D)
- Provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives.
- Prepare and/or co-ordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments in the Europe (EU, UK 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
- Represent EU Regulatory Affairs at cross-functional study management team meetings
- Research relevant regulatory precedents to understand the regulatory landscape
- Communicate and educate cross-functional teams on European regulatory requirements and changes in the regulatory landscape
- Participate in process improvement initiatives as required
- Maintain an effective archiving and submissions/approvals tracking records
- 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, Switzerland and United Kingdom. Experience with the new Clinical Trial Regulation would be an advantage.
- Knowledge of the European drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage).
- Start: 01.12.2022
- Duration: 30.11.2023
- Capacity: 5 days per week
- Location: Zug, Switzerland