Regulatory Affairs Manager (m/f)

2 jours restants

Région
Brussels
Publication
mardi 24 juillet 2018
Date limite
vendredi 24 août 2018
Réf
820CEXPE-BE
Contact
Carine Steurs
Fonction
Autre
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
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.


Job description:

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.)


Profile:

You have:

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.



Offer:

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.




Licenses
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

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