Regulatory Affairs Consultant - Netherlands
- 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.
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