Beschreibung
European Regulatory Affairs Manager -CTAs 100% (m/f/d)Project conditions:
- Location: Switzerland preferred- remote work possible.
- Start date: ASAP. Ideally
- Project duration: 12 months
- Workload: 40 hours per week.
- Language: English - fluent.
Role and Responsibilities:
- 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 as applicable
- Represent EU Regulatory Affairs at cross-functional study management team meetings.
- Anticipate and bring solutions for potential regulatory risks
- Maintain good knowledge of regulatory requirements and guidelines
- Research relevant regulatory precedents to understand the regulatory landscape applicable to development programs
- 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
- Support the European Regulatory team as required.
- Oversee team, ensuring efficiency and compliance with established policies and procedures
- Identify opportunities for process optimisation and implement best practices.
Your profile:
- 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)
If you are interested in this position contact me as soon as possible! Send your CV and salary expectations over our home page to Fabiola Miranda or per mail directly to
We are looking forward to getting to know you!
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.