Jobs in life sciences

Senior CMC writer

Ref. 156 – SCMCW
Function: The objective of this position is to generate qualitative reports and dossiers in collaboration with the dossier development team.
Location: Ghent

The company:

This company is a leading contract development organization for the pharmaceutical industry. They assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinics and market. They provide a comprehensive and integrated portfolio of drug substance and drug product development services.

Job description:

You will be responsible for writing and submitting regulatory documents (e.g. MAAs, IMPDs, Variations, etc.) and scientific reports for diverse projects. You will manage the life cycle of the drug product from the preparation and submission of the dossier towards the European and American authorities; to the launch of the registered drug on the market, as well as preparation of post-approval variations.

Your main goal is to ensure full compliance with regulatory requirements. To do so, you have a passion for (technical/scientific) writing and the drive to generate qualitative reports and dossiers in collaboration with the dossier development team.

The key responsibilities of the role

  • Authoring scientifically sound source documents related to drug development activities as well as scientific and statistical interpretation of the data.
  • Writing CMC regulatory documentation for new filings and clinical trials.
  • Preparation of variations for existing MAs, both writing and submission.
  • Follow-up of dossiers after submission until the MA is obtained and coordination of national finalization for EU countries, if needed.
  • Keep yourself up to date on all new laws and regulations concerning pharmaceuticals and medical devices.
  • Independent problem solving by offering practical solutions that are compliant with regulatory requirements.

Requested competences and skills:

  • You have a master’s degree in a life science discipline (pharmacy, biotechnology, chemistry).
  • You have 1 to 5 years of experience in a regulatory position (in early phase development, commercial phase and/or post-approval support).
    • Experience with EU and US regulations, is a must.
    • Experience with Japan, Canada, ROW, is a big plus.
    • Experience with regulations and guidelines for large molecules is a plus.
  • Excellent writing and communication skills.
  • Fluent in English written and spoken.
  • Customer-oriented and quality conscious attitude.
  • Eye for detail.
  • Proficiency with MS Office (mainly Word, Excel).
  • Well organized and able to handle multiple projects simultaneously.
  • Team player.
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