Our client, a leading biotechnological company based in Zug is searching for a Regulatory Affairs Specialist on Clinical Trials to join their team.
Start date: latest on 01/12/2022
End date: 30/11/2023
- Prepare and/or coordinate the preparation of regulatory documentation to support Clinical Trial Applications/amendments mainly in Europe (EU, UK, and Switzerland) and worldwide
- Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) to ensure optimal execution of the agreed regulatory strategy for the development of medicinal products
- Work with regulatory affairs consultants/service providers on CTA submissions
- Communicate and educate cross-functional teams on European regulatory requirements and changes in the regulatory landscape
- BSc; MSc or Ph.D. in a life sciences discipline
- At least 4 years of experience managing regulatory submissions, with a primary focus on clinical trial applications
- Knowledge of the European drug development process and regulatory requirements. Experience with the new Clinical Trial Regulation would be an advantage
- Fluent in English
What's on offer?
Our client offers an exciting position in a fast-paced and collaborative small-company environment. Does this description sound like you? If so, please get in touch, and you could be embarking on a new and exciting professional opportunity.
For further information or to apply, please contact Asher Cos, recruiter:
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