|Publication date:||May 27 2021|
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.
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.
The ideal candidate would have:
In return for your efforts, you will:
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Senior Associate | Clinical Research
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