BrightOwl Loader Loading

Regulatory Affairs Consultant - Netherlands  

Company managed [?] Still accepting applications

Posted on : 13 July 2017

Project Description

  • 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 and ability to put yourself in the position of our clients