Regulatory Affairs Manager (m/f)
2 jours restants
- Temps de travail
- Temps plein
That's XPE. For one of our clients we are looking for: Regulatory Affairs Manager (m/f) Organisation description:
Our client promotes cancer research in Europe and is linked to other leading biomedical research organizations.
As a Senior Regulatory Affairs Manager (Sr RAM) you play a role in the management of the Regulatory Affairs Department for workload planning and staff coaching throughout the whole life cycle of the clinical trial applications across Europe.
Your function will Include but is not limited to:
• First entry port of any new project that requires regulatory advice during the planning phase.
• Provide ongoing updates on changes in the regulatory environment
• Advise on and review regulatory documents to ensure compliance with applicable regulations and propose actions, if required
• Ensure together with the Head of Dept. initial and continuous training as well as personal development & regulatory advice to all members of the RAU
• Support the Head of Department in the development of procedures and templates
• Back up of the Head of Dept. at relevant meetings (General team meetings, meetings with industry etc.)
• Master degree in life Sciences
• 8 years of relevant experience in international clinical trial regulatory environment from a sponsor perspective in a management/decision making position
• Good knowledge of current and future EU regulatory environment and related impacts on the work organization.
• Can demonstrate the ability to coordinate work transversally with other units, reach deliverables by deadlines
• Can demonstrate expertise in QC of regulatory submission documents
• Excellent proven team management experience, familiar with project management tools for planning
• Good organization skills, ability of multi-task
• Excellent written and verbal English skills.
Full time contract and a competitive salary including an extra-legal package. You gain experience in an innovative, collaborative working environment with room for creativity and growing your career.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713