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REGULATORY/CLINICAL COORDINATOR

NOVADIP BIOSCIENCES is an innovative biotech company, based in the Walloon Region (Mont-Saint-Guibert), with a strong expertise in the development of a unique 3M³ tissue regeneration platform, which utilizes adipose-derived stem cells within a 3-dimensional extracellular matrix, to drive multiple product classes, Novadip’s mission is to provide innovative solutions for patients with limited or no effective treatment options.

 

If you are sharing the vision of developing life-improving and life-saving products and if you are looking for new challenges amongst a dynamic and innovative team, consider collaboration with this fast-growing company.

In order to support this challenging development, NOVADIP BIOSCIENCES is actively looking for (m/f/x):

 

REGULATORY/CLINICAL COORDINATOR

 

Position Summary/Objectives:

  • Coordination/logistical/operational support of regulatory and clinical trial activities (focus in EU and FDA)
  • In-house management of related documentation

Responsibilities:

  • Plan/track activities related to regulatory procedures and clinical development
  • Systematic communicator of submission timelines and regulatory status to relevant parties
  • Maintenance of relevant and dedicated filing systems, with specific focus on (regulatory/clinical) compliance with international standards
  • Logistic support for Health Authority meetings, Advisory Boards, investigator meetings, and any other meetings for assigned project(s)
  • Communication with service providers related to projects.
  • Departmental central point for contacts and planning/ organization.
  • Develop/ensure maintenance planning, tracking/monitoring of processes.
  • Take part in training and integration of new company member

Profile:

  • Minimal 5 years hands-on experience in regulatory department and/or clinical trial development, or in a similar function
  • Proficiency with database management and system templates
  • Excellent command of spoken and written French and English
  • Proven IT skills (eg Excell, Word, Powerpoint, ….)
  • Ability to rapidly adapt to different issues and projects
  • Excellent interpersonal and general communication skills
  • Understanding of the pharmaceutical industry

 

Offer:

  • A part-time permanent position in a growing team
  • To work in a human-sized, dynamic, respectful and professional environment
  • The opportunity to take part in a challenging scientific and business growth
  • An attractive salary package with advantages

 

Interested?

Please send your CV to careers@novadip.com. Your application and related information will remain strictly confidential.