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Consultant Regulatory Affairs Tilburg Netherlands,  

3DPharmXchange (company)

Posted on : 20 February 2017

Project Description

Company profile
  • Our company is a Dutch Life Sciences consultancy and operational support firm.
  • We are dedicated to the development of pharmaceuticals and diagnostics. 
  • Our team of experts aims to cover the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management.
  •  In addition we provide out-licensing and interim management support.
  •  Our clients are leading big pharma companies as well as innovative biotech start-ups.

Job description 
  • For the development of the various projects we run for our clients, we are looking for a regulatory affairs expert with at least 7 years experience in global regulatory affairs, who is able to look beyond his or her borders and has an ambition to grow in a young and growing organization.

Requirements & roles 
  • Knowledge of and experience in global regulatory requirements (including CMC) for the development and registration of new medicinal products (chemical entities and biologicals) 
  • Knowledge and experience in CMC regulatory affairs is a pre 
  • Experience in preparation and submission of clinical trial applications 
  • Experience in preparing regulatory strategies for all stages of drug development 
  • Experience in writing and reviewing documents for specific global regulatory purposes, e.g. investigators  brochures, CMC, nonclinical and clinical dossier (eCTD) overviews/summaries, DSURs/PSURs, pre-IND/End-of-Phase 2/scientific advice briefing/background packages, target product profiles, product information/labeling documents, risk management plans (RMPs), agency response documents, etc. 
  • Experience in preparation and submission of scientific advice and orphan designation applications and peadiatric investigational plans (PIPs) 
  • Experience in companion diagnostic regulations is a pre 
  • Experience in contacts and meetings with regulatory agencies 
  • Project coordination and project team participation 
  • Demonstrated competency and experience in all stages of drug development within the pharmaceutical industry 
  • Essential communication skills: good oral, writing and presentation skills 
  • Essential personality skills: 
    • pro-active, team player,
    •  entrepreneurial, 
    • can work under time pressure, 
    • can-do mentality 
    • ability to put yourself in the position of our clients.


5026 SK Tilburg The Netherlands

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