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You will act as a trusted quality and compliance advisor. You will help teams navigate complex regulatory requirements, strengthen quality processes, manage risk and continuously improve the way clinical trials are delivered. Monitor the regulatory
Design and deliver clinical performance study strategy, protocols, and reports for IVDR and CDx programs. Define and address clinical evidence requirements, providing clinical input into product risk evaluation and study design. Partner closely with
Contribute to the development of the audit strategy & program and plans related to the GVP area-PV processes, vendors, Partners and affiliates; Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head; Perform and coordinate PV
The successful candidate will serve as Lumis' medical device regulatory subject matter expert, leading project delivery, supporting business growth, enhancing industry visibility, and further developing the Lumis brand as a recognized provider of medical
Define and execute EU regulatory strategies in alignment with global development plans. Serve as primary EU regulatory contact with EMA and coordinate interactions with National Competent Authorities. Lead preparation and execution of Scientific Advice,