Description
One of our clients, a multinational company in the pharmaceutical industry currently requires a Regulatory Affairs Diagnostic
Start: ASAP
MISSION DESCRIPTION
* Provide diagnostic regulatory expertise to the teams developing tests for use in the ASCI program
* Work closely with the therapy vaccine regulatory project teams to ensure that the diagnostic and therapeutic regulatory strategies are aligned
* Work with partner companies to ensure regulatory authorization is obtained, and regulatory compliance maintained, for the companion diagnostics necessary for the ASCI program (either for clinical trials or for marketing)
PREREQUISITES
Education:
* Science graduate preferably with a Masters or Doctorate a degree inanalytical/clinical biochemistry or molecular biology is an advantage
* Preferably, some formal training (academic or non-academic) in regulatory science
Knowledge/Skills:
* Preparing and managing regulatory submissions
* High-level scientific writing (ability to condense complex technicaltopics to a clear and concise story)
* Able to define, and defend, a controversial position within a team
* Flexibility to adapt to a new culture quickly and effectively
* Fast learner with the ability to demonstrate critical analysis of complex problems (and details) to peers and managers
* Proactive, enthusiastic, and able to function in a complex matrixorganization
* Fluent spoken and written English (able to cope with complex meetingsand scientific writing)
Experience:
* At least 6 years IVD company (preferably roles in more than one discipline including technology/product development or QA)
* At least four years IVD Regulatory (pre- and post-market); additional experience in device, pharma, or biologics an advantage
* Experience with managing/coordinating global (or multi-region)regulatory submissions
* Demonstrated success within a complex multi-billion dollar company
* Experience with companion diagnostics, cancer diagnostics and/orqPCR is an advantage but not essential
Location:
* Rixensart or other European location (including home office) with ability to be on site when necessary (3 days a week)
* Willingness to travel up to 25% (though average will be less)
Tags: Regulatory, Diagnostics, therapeutic, RA, Affaires règlementaires, submissions, pharmaceutical