Merus zoekt een
Associate Director Regulatory Affairs CMC (36-40 hrs)
Utrecht, Netherlands
Join our mission to close in on cancer.
The team:
As a member of our CMC (Regulatory Affairs team you will play an important role in managing, writing, preparation and review of RA-CMC regulatory filings for submissions of Merus’ product candidates in compliance with the applicable regulatory and quality requirements, as well as providing biopharmaceutical CMC-content related regulatory advice to the rest of the CMC team.
The role:
As Regulatory Affairs CMC Officer, your main tasks and responsibilities are the following:
- Preparation and co-review of CMC sections of regulatory filings;
- Managing Regulatory Affairs CMC-related projects of Merus’ product candidates both internally (with Merus colleagues) and externally (third parties);
- Ensuring that CMC regulatory filings are in compliance with internal procedures, regulatory guidelines and according to GMP, GLP and/or GDP, where applicable;
- 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;
· Managing the communication and follow-up with Competent Authorities on CMC regulatory related feedback received;
Your profile:
We are looking for a Regulatory Affairs CMC Manager, with the following knowledge and expertise:
- You hold a Master’s degree in a relevant biomedical field, and have at least 3 years of relevant working experience within the (bio)pharmaceutical industry, or other relevant regulatory experience;
- You have a good understanding of Regulatory Affairs (EU/US/ROW)
- You have good understanding of various quality systems such as GMP, GLP and GDP;
- You are a team player focused on results;
- You have an analytical mindset and attention for details;
- You are known for your organization skills and drive to continuously improve your work;
- You communicate well in English, both verbally and in writing.
Why Merus?
We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll experience a steep learning curve from your very first day in the job. And you’ll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours, an excellent pension scheme, a company bonus and 30 days’ annual leave (based on a full-time position). Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.