Regulatory CMC Writer

  • Ghent, BE
  • 11 months ago

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

The Ardena Group is operating from six sites in Europe. For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for a

Regulatory CMC Writer

Your key role

Ardena’s Dossier Development team brings tailored and timely services to our customers in the very broad sense of regulatory services. We provide support by writing and submitting regulatory documents (e.g. MAAs, IMPDs, variations, etc.) but also scientific reports for diverse customers & projects. At Ardena, we are experts in writing scientific reports using a dossier-centric approach. This means we keep the final dossier submission in mind throughout in order to ensure consistency, completeness and readability.

Your key responsibilities

  • Ensure full compliance with regulatory requirements
  • Prepare and write CMC dossier-centric scientific reports which will be used as basis for global regulatory submissions (MAA, NDA, BLA)
  • Prepare and write the CMC documentation needed for clinical trials (IMPD/IND)
  • Interpret and apply global/regional CMC regulatory guidelines and regulations

Your profile

Education and experience

  • Master’s degree or Ph. D. in a scientific discipline e.g., pharmacy, biotechnology, bioengineering, biomedical sciences or similar.
  • You are familiar with regulatory CMC writing (EU) or you have regulatory knowledge of (bio)pharmaceutical manufacturing and development

General Skills

  • Strong writing skills
  • Very good communication skills (both written and spoken)
  • Very good knowledge of English is required
  • Taking ownership
  • Problem-solver
  • Well organized and able to handle multiple projects in parallel
  • Ability to work independently and under time-pressure
  • You have a proactive attitude, and you dare to think out-of-the box
  • Customer-oriented and quality conscious attitude
  • Eye for detail
  • Proficiency with MS Office (mainly Word, Excel)
  • Eager to learn

We offer

  • An attractive and tailor-made remuneration package including extra-legal benefits
  • Ability to grow your experience and skills in a rapidly growing company with international customer portfolio
  • A dynamic working environment

If interested, please contact us and send us your cv and motivation letter via our website ardena.com/careers or email at hr@ardena.com