Vacancy Regulatory Affairs CMC Specialist – Utrecht


Organization

For a mid-sized international organisation fighting against cancer, we are looking for a Regulatory Affairs CMC Specialist. Due to the success of their work they are close to going from a clinical stage organisation to having their first treatment on the market. With a diversified oncology pipeline more is to come. Therefore, they are steadily growing resulting in creating this new position for you to engage. It’s a pleasure to work here, not only because you are part of something impactful in oncology but also because they value humour, solidarity and teamwork. They have a great atmosphere to work in, an energy that you can even feel conversing via Teams or Zoom. What is also good to know is that they are a multi cultural and international organisation with sites all over the world and close to opening a new office in the Netherlands. The origin is also Dutch and the new office is coming also because of the growth and the design is quite incredible. Within the team which is quite harmonious and full of positivity they are very transparant and appreciate clarity, you will function as the right hand of the Senior Director and therefor take on an important role in this company, having one leg in the strategy and one leg in operations.

Function

In this role you will be preparing and co-reviewing the CMC sections of regulatory filings, manage Regulatory Affairs CMC-related projects both internally and externally. You will ensure that CMC regulatory filings are in compliance with internal procedures, regulatory guidelines and according to GMP, GLP and/or GDP guidelines. Besides that you will provide regulatory advice on CMC technical and quality matters to the rest of the CMC team, such as manufacturing process development, specifications, in process controls, and change control management. And you will be managing the communication and follow-up with Competent Authorities on CMC regulatory related feedback. As the right hand of the Senior Director you will be the go-to person for in-depth questions both internally as externally and will provide feedback and input on strategy.

Requirements

The ideal candidate would have:

  • A MSc degree in a relevant biomedical field
  • Five years of relevant working experience within the biopharmaceutical industry, or other relevant regulatory experience
  • Good knowledge and understanding of Regulatory Affairs (EU/US/ROW)
  • Good knowledge and understanding of various quality systems such as GMP, GLP and GDP
  • A team spirit focused on results
  • An analytical mindset and attention for details
  • Organisation skills and drive to continuously improve your work
  • Fluent in English, both verbally and in writing

Offer

In return for your efforts, you will:

  • Receive a competitive salary within the range of € 90,000.- gross per year
  • Be part of a truly impactful journey to fight cancer and change healthcare
  • Enjoy a team that is harmonious, driven and full of humour
  • Receive extra secondary benefits such as 30 holidays, a bonus and stock options

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Yvo Selderbeek
Senior Associate | Clinical Research

+31 6 12 57 66 48
+31 23 754 86 60
y.selderbeek@qtcrecruitment.com