For my customer in Baden-Württemberg, an international and well respected CRO, I am looking for a regulatory specialist for European clinical trials.
You will be responsible for:
- the compilation and submission of regulatory documents to international ethics committees and health authorities for clinical trials
- preparing and carrying out quality checks on Clinical Trial Applications
- processing study documentation from the clinical trial sites
- tracking and filing all correct and complete study documentation in Trial Master Files (TMF)
- communicating with sponsors and forwarding all relevant regulatory documentation
- responding to deficiency letters after interaction with sponsors
- compiling site regulatory documentation for Investigator Site Files
- you will also work closely with other departments and colleagues (PMs, CRAs and CTAs).
- University degree in a related field (Chemistry, Biology, Pharmacy)
- At least 5 years' relevant experience (managing regulatory tasks for clinical trials)
- Experience with ethics committee submissions
- Fluent English (other languages are an advantage)
If you are looking for a new challenge and want to join an international company, then you should seize this opportunity.
The next step:
To apply for this position, please send me your CV and salary expectations by email.
Andrew Pride - Regulatory Affairs
Principal Recruitment Consultant
T: +49 (0) 89 - 5519 7767
Progressive München - Pharma
Die Personalberatung SThree betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.