3D-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.
For the development of the various projects we run for our clients, we are looking for a regulatory affairs expert to join our team of regulatory affairs consultants. The ideal candidate is able to look beyond his or her borders and has an ambition to grow in a young and growing organization. Coaching will be provided in specific areas if needed.
Master degree in Life Sciences, e.g. Biomedical Sciences, Medical Biology, Pharmacy, Chemistry
At least 3 years of experience in a regulatory affairs role
Communication skills: good oral, writing and presentation skills
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.
Experience in a number of the following areas and roles (not all required):
Knowledge of and experience in global regulatory requirements for the development and registration of new medicinal products (chemical entities and biologicals)
Knowledge and experience in CMC regulatory affairs
Experience in preparation and submission of clinical trial applications
Experience in preparing regulatory strategies for all stages of drug development
Experience in writing and/or reviewing documents for specific global regulatory purposes, e.g. investigators’ brochures, 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 pediatric investigational plans (PIPs)
Experience in companion diagnostic regulations
Experience with additional Risk Minimization Measures
Experience in interactions 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
Send your CV and short motivation letter to Nina Lemmers-van Erp atnina@3d- pxc.com. For more information, you can also contact her at +31 (0)13 53 482 72