This job is currently Archived,
Posted on : 20 February 2017
Company profile3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and the Pivot Park in Oss. 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. Interested? Send your CV and short motivation letter to 3D-PharmXchange at email@example.com. For more information you can contact Ronald van der Geest on +31 (0)13 5348272. Acquisition is not appreciated!
5026 SK Tilburg The Netherlands
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