Job Properties
  • Job Type
    Full-time Position
  • Background
    Biotech and Agricultural
    Engineering
    Medical and Healthcare
    Other Science and Tech
  • Languages
    English
  • Experience Required
    1 - 2 Years
  • Degree Required
    Bachelor
    • Province
      3D-PharmXchange
    • Date Posted
      April 07,2021
    • VISA
    • MOCKINTERVIEW
    • IMG_6430
    • Career Consultation
    • COVERLETTER CHECK
    • CV CHECK
    • internship package

    Consultant Regulatory Affairs - CMC

    Company profile

    3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and a side office in Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, chemistry, manufacturing and control (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 various projects that we are running for our clients, we are looking for a consultant Regulatory Affairs – CMC). As a CMC Regulatory Affairs consultant, you will be working in a multi-disciplinary team and will be responsible for giving the team (incl. e.g. the CMC lead, process development rep, analytical rep) regulatory guidance and direction in order to finally arrive at a dossier that will meet regulatory expectations. The CMC regulatory consultant must be able to both provide support in developing CMC regulatory strategies as well as be hands on and deliver regulatory documentation related to CMC, including e.g. comparability protocols and CMC sections of regulatory documents such as IMPD and IND.

    Tasks

    • MSc or PhD in the area of (Analytical) Chemistry, Pharmaceutical Sciences, or Bio(process)technology
    • Knowledge and experience in CMC regulatory affairs
    • At least 5 years of experience in a comparable position and/or work environment is preferred
    • Essential communication skills: fluency in English, oral, written and presentation skills
    • Extensive experience in writing documents for regulatory purposes
    • Essential personality skills: pro-active, team player, entrepreneurial, can-do mentality and ability to put yourself in the position of our clients

    In addition, we expect a Consultant Regulatory Affairs – CMC to meet at least some of the following requirements;

    • Demonstrated competency, experience, and knowledge on CMC development and manufacturing requirements from early to late phase within the pharmaceutical industry
    • Preferrably experience with both small molecules and biologicals
    • Experience with health authority interactions
    • Experience in project coordination and project team participation

    Interested?

    Send your CV and short motivation letter to Nina Lemmers-van Erp at nina@3d- pxc.com. For more information, you can also contact her at +31 (0)13 53 482 72

     
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