Regulatory Specialist - Clinical Research, South Germany

Location: Baden-Württemberg, Deutschland Salary: k.A.
Sector: Life Sciences Type: Festanstellung

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).

Your qualifications:

  • 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

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