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Regulatory Affairs Specialist on Clinical Trials

Swisslinx
Zug, Schweiz
Gepostet vor 5 Tagen Befristet Competitive
Regulatory Affairs Specialist on Clinical Trials
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
Extension: possible
Location: Zug

Your mission:

- 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

Your background:

- 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: asher.cos@swisslinx.com
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA

I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
Job ID  14506
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