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- regulatory submissions associate
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Regulatory submissions associate • suisse
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CK GroupSwitzerlandJob Title : Senior DRA Clinical Trial Manager
Location : Allschwil, Switzerland
Work Schedule : Full-time (100%)
Start Date : ASAP
Duration : 12 months (Contract)
We are looking for a Senior Clinical Trial Manager, to join our clients dynamic team in Allschwil. If you're passionate about regulatory affairs and ready to make an impact in the clinical trial space, we want to hear from you.
Key Responsibilities : Clinical Trial Applications (CTAs) :
- Provide regulatory input and guidance for clinical trials across Europe and internationally.
- Prepare, submit, and maintain CTAs according to current regulatory requirements.
- Liaise with internal teams and external service providers (ESPs) to gather and manage submission documents.
- Communicate with Health Authorities (HAs) and ensure all regulatory deadlines are met throughout the trial lifecycle.
- Maintain up-to-date tracking sheets and documentation for CTA submissions, amendments, End of Trial notifications, and Clinical Study Report (CSR) synopses.
- Ensure accurate filing in electronic and paper Trial Master Files (TMFs).
Clinical Trial Team (CTT) Involvement :
Additional Responsibilities :
Your Profile :
Why our client
Our client is more than a pharmaceutical company they are a global team driven by a shared purpose. Join a collaborative environment, where innovation is encouraged, and your expertise will contribute to life-changing therapies worldwide.
Apply :
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.